December 27, 2001
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has granted supplementary approval to Novo Nordisk Pharmaceuticals allowing the use of its rapid-acting insulin analog NovoLog (insulin aspart [rDNA origin]) with external insulin pumps.
The approval makes NovoLog the first and only insulin analog to be indicated for use with the pumps, according to Novo Nordisk.
NovoLog is used to control hyperglycemia in adults with type II diabetes. The product, approved by the FDA in June, has been available in the US since September, 2001. It's sold in cartridges for Novo Nordisk's NovoPen and Innovo delivery devices and in vials for the external pumps or for syringe delivery.
NovoLog has a rapid onset and relatively short duration. It's ordinarily used as part of a regimen that includes intermediate or long-acting insulin.
Novo Nordisk said it soon plans to launch a combined blood glucose monitoring and insulin dosing system called InDuo, which will be appropriate for use with NovoLog cartridges.
December 19, 2001
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given approval to Kos Pharmaceuticals Inc. to market three strengths of Advicor (extended-release niacin/lovastatin), a combination tablet for mixed lipid disorders.
In July, Kos said it received a FDA approvable letter. Final approval was delayed until the December 15 expiration date of Merck & Co. Inc.'s marketing exclusivity for the lovastatin.
In conjunction with the approval, Kos said it received $45 million from Bristol-Myers Squibb to terminate its earlier co-promotion arrangement with DuPont Pharmaceuticals for the cholesterol product. Kos said the payment would strengthen the company's ability to launch Advicor without a marketing partner, using 450 field representatives.
December 17, 2001
(MD Consult) - The US Food and Drug Administration (FDA) has approved pimecrolimus (Elidel Cream 1%), a treatment for atopic dermatitis made by Novartis Pharmaceuticals.
The product will be the first non-steroid prescription cream for mild to moderate atopic dermatitis in patients 2 and older, Novartis said. Pimecrolimus is used for short-term and intermittent long-term treatment of patients who don't respond well to or experience side effects with conventional treatments, the firm said.
Novartis plans to market Elidel in the US in early 2002. The company has also filed marketing applications for Elidel in Demark, Switzerland and Canada.
Novartis will study the product in infants who have a significant need for new therapeutic alteratives.
December 17, 2001
(MD Consult) - Novartis also said it had received an approval letter from the FDA for its antiepileptic drug oxcarbazepine (Trileptal) as monotherapy in treating partial seizures in children as young as 4.
Trileptal is currently approved as monotherapy and adjunctive therapy for adults and as adjunctive therapy for children between the ages of 4 and 16.
Five other antiepileptic drugs are approved as monotherapies for children, but can have serious side effects or require frequent blood tests or complex dosing and titration schedules, Novartis said.
Trileptal has a favorable side-effect profile, with no black box warning and no links to aplastic anemia, agranulocytosis, hepatotoxicity or pancreatitis, according to Novartis. No monitoring of liver functions and blood counts is required for Trileptal patients, Novartis said.
December 11, 2001
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has granted approval to French biopharmaceutical maker Sanofi-Synthelabo and Dutch chemical conglomerate Akzo Nobel to market their novel antithrombosis therapy, Arixtra (fondaparinux sodium).
The companies said they received FDA approval to market the drug for the prophylaxis of deep vein thrombosis in patients undergoing hip fracture surgery, hip replacement surgery or knee replacement surgery. Arixtra is the first synthetic anticoagulant to receive approval for these indications, according to the FDA.
Arixtra, the first of a new class of agents intended to inhibit Factor X, was discovered by Sanofi-Synthelabo in conjunction with Akzo Nobel subsidiary Organon Pharmaceuticals.
The US launch should occur in the first quarter of 2002, the companies said. Arixtra is under regulatory review in the European Union.
Sanofi-Synthelabo said clinical investigations are being conducted to extend the presently approved indications.
December 5, 2001
ST. LOUIS (MD Consult) - The US Food and Drug Administration has given approval to Bayer Corporation to market an intravenous formulation of Avelox (moxifloxacin), a broad-spectrum antibiotic in the same class as Bayer's Cipro (ciprofloxacin).
West Haven, Connecticut-based Bayer said the FDA granted approval to market the IV formulation for the treatment of community-acquired pneumonia, acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis, plus uncomplicated skin and skin structure infections. The drug is for adults.
Bayer said it is considering Avelox for the treatment of intra-abdominal and complicated skin infections.
The FDA approved the tablet formulation of Avelox for the treatment of common adult respiratory tract infections in December 1999. In April of 2001, the agency expanded that indication to include uncomplicated skin and skin structure infections.
November 30, 2001
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved Merck & Company Inc.'s Invanz (ertapenem sodium), its structurally unique, once-a-day, injectable beta-lactam antibiotic.
The FDA approved the once-a-day injectable formulation for moderate-to-severe adult bacterial infections caused by gram-positive and gram-negative aerobic and anaerobic bacteria, according to Whitehouse, New Jersey-based Merck. The firm plans to launch the antibiotic during the first quarter of 2002.
Merck wants to sell Invanz to hospitals as a first-line treatment for complicated intra-abdominal, skin, and skin structure infections. The antibiotic's coverage and empirical profile combined with its ease of administration should make Invanz an ideal first-line treatment for these common infections, Merck said.
Unlike other carbapenems, Invanz doesn't cover certain hospital-acquired pathogens such as Pseudomonas and Acinetobacter, Merck said. Approval was based on data from 13 clinical trials involving 1900 patients with complicated intra-abdominal infections, complicated skin and skin structure infections, community-acquired pneumonia, complicated urinary tract infections and acute pelvic infections.
Therapy with Invanz ranged from 3 to 14 days. Primary analysis was the assessment of response to treatment at a prespecified post-therapy visit. The most frequent side effects included diarrhea, nausea, headache, infused vein complications, vomiting, vaginitis, and vein inflammation.
November 26, 2001
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given approval to biopharmaceuticals maker Actelion Ltd. to market Tracleer (bosentan), its orally active endothelin receptor antagonist for treating pulmonary hypertension.
Tracleer is the first oral treatment for pulmonary arterial hypertension to be approved for sale in the US, according to the firm and the FDA.
Allschwil, Switzerland-based Actelion intends to begin shipments in December, 2001. The firm has signed a co-promotion agreement with San Francisco, California-based Genentech Inc., but that agreement won't take effect until Actelion has completed on-going phase III trials of Tracleer for the treatment of chronic heart failure (CHF).
The company said the drug received orphan drug status in the US, European Union and Australia for the pulmonary arterial hypertension indication. Tracleer is undergoing regulatory reviews for marketing approval in the European Union (EU), Canada, Switzerland and Australia.
The FDA said use of Tracleer would be restricted to a direct distribution program due to the drug's possible side effects, including potential liver toxicity and damage to a fetus, and it won't be available in commercial pharmacies. The drug would also carry a black box warning on the label to highlight those risks, the FDA said, and would be distributed along with an easy-to-read consumer guide to explain its potential side effects.
Because of its potential to cause birth defects and affect the performance of contraceptives, the FDA said the drug would also be contraindicated for use with hormonal contraceptives.
The approval was based in part upon the recommendation of the FDA's Cardiovascular and Renal Drugs Advisory Committee, which found that Tracleer is an effective treatment for the rare but potentially fatal disorder. The committee's recommendation was based on the evaluation of two clinical studies of 245 patients, in which Tracleer use resulted in an improvement in the 6-minute walking test of 35 meters compared with placebo in one study, and 54-meter benefit in another study compared to a placebo.
In the US, Tracleer is also being considered as a possible treatment for children under age 12 and as a concomitant treatment for patients on intravenous prostacyclin therapy, the company said .
November 26, 2001
ST. LOUIS (MD Consult) - GlaxoSmithKline's dutasteride, for the treatment of benign prostatic hyperplasia (BPH), has been approved by the US Food and Drug Administration (FDA)
GlaxoSmithKline officials said the agency had approved the drug, a 5-alpha reductase inhibitor.
GlaxoSmithKline said dutasteride is the first 5-alpha reductase enzyme inhibitor to inhibit both enzymes responsible for converting testosterone to dihydrotestosterone in the prostate, which is a key process in the development and progression of BPH. The drug has been tested on more than 4,300 BPH patients in clinical studies and has demonstrated long lasting symptom relief and positive impact on disease progression, GlaxoSmithKline said.
Other products currently on the market to treat BPH include Merck's Proscar (finasteride), Abbott Laboratories' Hytrin (terazosin), Pfizer's Cardura (doxazosin) and Sanofi-Synthelabo's Xatral (alfuzosin), all of which are alpha-1-adrenergic blockers.
The London-based firm filed for European marketing approval of dutasteride with Swedish regulatory authorities in early October.
November 26, 2001
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved Eli Lilly & Co.'s Xigris (drotrecogin alfa), the first biologic treatment for sepsis, a systemic infection characterized by coagulation and inflammation that can lead to organ failure.
The treatment, a genetically engineered version of the naturally occurring protein Activated Protein C, was created to mimic the apparent ability of the protein to balance the body forces that cause inflammation, clotting and bleeding.
In October, advisors to the FDA divided on whether the agency should approve the drug, primarily due to concerns about the deaths of four Xigris users who bled to death. Some panelists were also concerned about the company changing its original clinical trial before completion to exclude patients likely to die from causes other than sepsis.
Despite these concerns, the agency approved the drug for treatment of adult patients with severe sepsis who have an especially high risk of dying from sepsis, as determined by a scoring system based on general health and illness severity.
In clinical studies involving 1,700 patients, the overall rate of mortality among patients taking Xigris was reduced by 6% during the 28-day study period, the FDA noted. The treatment did not lower mortality rates among patients who were less severely ill, but it reduced the mortality rate by 13% among patients who have a greater risk of dying -- the group the drug is now indicated for.
Xigris isn't advised for patients with internal bleeding or who are more likely to bleed due to medical conditions including stroke, head or spinal surgery and severe head trauma.
November 21, 2001
ST. LOUIS (MD Consult) - The Ortho Evra patch, the first-ever transdermal hormone patch used as a weekly form of birth control for women, has been approved by the US Food and Drug Administration.
The Ortho Evra patch, developed by Ortho-McNeil, will be made and marketed by RW Johnson. Both companies are part of Johnson and Johnson in Raritan, New Jersey.
Ortho Evra, a one and three-quarter inch patch containing norelgestromin and ethinyl estradiol, is intended as an alternative to oral contraceptives. Once attached, the patch offers regular transdermal delivery of the hormones for 1 week, RW Johnson said.
Ortho Evra should be applied to the lower abdomen, buttocks, upper body or upper outer arm only, the firm said. Each patch should be worn for 7 days before being replaced with a new patch on the same day of the week.
The schedule should be maintained for 3 weeks, with no patch being applied in the fourth week, Ortho Evra said. As with oral contraceptives, the treatment-free week allows a woman to have her period.
The patch prevents pregnancy when used as directed, RW Johnson said. The hazards associated with its use are similar to those of oral contraceptives, including an increased risk of thrombosis, myocardial infarction and stroke. As with oral contraceptives, smokers are warned against using Ortho Evra due to an increased risk of serious cardiovascular side effects, the company said.
In clinical trials comparing the patch to oral contraceptives, about 5% of women said they had at least one patch fall off, while 2% stopped using Ortho Evra due to skin irritation, the firm said. Further, the FDA notes the patch is less effective in women weighing over 198 pounds.
November 20, 2001
ST. LOUIS (MD Consult) - A new Cox-2 inhibitor made by Pharmacia, offering a once-a-day treatment regimen for osteoarthritis, has received marketing approval from the US Food and Drug Administration (FDA), pharmaceutical makers Pharmacia Corp. and Pfizer Inc. jointly announced.
The companies said Pharmacia received approval for Bextra (valdecoxib tablets), a Cox-2 inhibitor that would also be indicated for the treatment of adult rheumatoid arthritis and menstrual pain.
Pfizer is Pharmacia's co-promotion partner.
The approval of Bextra was based on global clinical trials involving more than 5,000 patients, the companies said. In those trials, the companies said the 10 mg tablet of Bextra taken once daily was shown to be as effective as the commonly prescribed doses of other NSAIDs, including ibuprofen, diclofenac and naproxen for the treatment of osteoarthritis.
The exact launch date and price per dose hasn't been determined.
November 15, 2001
ST. LOUIS (MD Consult) - The US Food and Drug Administration has approved Amgen's Kineret (anakinra) for rheumatoid arthritis in adult patients who haven't benefitted from conventional disease-modifying antirheumatic drugs (DMARDs).
Kineret, a direct and selective blocker of the protein interleukin-1 (IL-1), is an injectable drug designed to inhibit the inflammatory response associated with rheumatoid arthritis.
Approximately 2.1 million Americans suffer from rheumatoid arthritis and about 300,000 of those people don't do well on traditional drugs, according to Amgen.
Amgen expects to have Kineret on pharmacy shelves soon. Kineret is used to reduce the signs and symptoms of moderately to severely active rheumatoid arthritis. It can be used as monotherapy or in combination with DMARDS other than TNF-blocking agents.
Approval was based on clinical trials involving 2,932 patients. In those trials, 38% of treatment-group subjects achieved a 20% improvement in American College of Rheumatology criteria within six months, while only twenty-two percent of placebo-group subjects achieved that level of improvement.
Treatment effects were generally seen by week 13, Amgen said.
The most common side effects included a mild injection site reaction. There was also a small risk of serious infection, Amgen said, but most patients can continue receiving the injection after the infection has resolved.
November 12, 2001
ST. LOUIS (MD Consult) - A longer-acting triptan for treating migraine in adults has received marketing approval from the US Food and Drug Administration (FDA).
Dublin, Ireland-based Elan Corporation said it received FDA approval for frovatriptan succinate (Frova), a tablet for acute treatment of migraine with or without aura.
Frova, formerly called Frovelan, is a selective 5-hydroxytryptamine (5-HT) receptor agonist thought to inhibit the dilation of arteries associated with migraine attacks.
Elan licensed exclusive North American sales and distribution rights to the drug from UK-based Vernalis in 1998.
Frovatriptan has also received approval in France, which is serving as the reference member state for the EU. Menarini, which will market the drug in Europe under the brand name Migard, plans a launch in the first half of 2002.
Frova has a 26-hour half-life. Currently marketed triptans have half-lives of 6 hours or less. Migraine headaches usually last between 4 and 72 hours.
Elan won't release pricing information until the product launches because it is still considering co-promotion partners. Elan plans to complete its launch plans before the end of this year.
October 30, 2001
ST. LOUIS (MD Consult) - Viread (tenofovir disoproxil fumarate), a new antiviral drug indicated for treatment of HIV-1 infection in combination with other antiretroviral medicines, has been approved by the United States Food and Drug Administration (FDA).
Tenofovir disoproxil fumarate is the first nucleotide analog approved for HIV-1 treatment. Nucleotides are similar to nucleoside analogs, and block HIV replication in the same manner.
The introduction of potent antiviral drugs and the combined use of these drugs has markedly reduced replication of HIV in many patients and has improved survival rates. But HIV mutates rapidly, so resistance to one or more of these drugs may develop over time, requiring the development of new drugs to treat these resistant virus strains.
The FDA based its approval of tenofovir disoproxil fumarate on two clinical studies involving more than 700 patients who had previously been treated with antiretroviral agents, but showed signs of continued HIV replication despite drug therapy. The two clinical studies were a placebo-controlled 24-week study and a controlled dose-ranging 48-week clinical trial. Patients who received tenofovir disoproxil fumarate showed significant decreases in the quantities of HIV RNA in their blood compared to patients who received a placebo with the standard antiretroviral regimen.
The approval of tenofovir disoproxil fumarate was based on clinical trials involving patients who were previously treated with antiretrovirals, so the risk-benefit ratio for untreated patients has yet to be determined. Furthermore, there are no study results to show long-term inhibition of the clinical progression of HIV by tenofovir.
Tenofovir disoproxil fumarate is available as a 300 mg tablet to be taken orally, with food. The use of tenofovir disoproxil fumarate should be considered for treating adult patients with HIV strains that are expected to respond to tenofovir as assessed by laboratory testing or treatment history.
The most frequently reported side effects among patients in the clinical trials were mild to moderate gastrointestinal problems including diarrhea, nausea, vomiting and flatulence. Lactic acidosis and hepatomegaly with steatosis (severe liver enlargement and excess fat in the liver) have also occurred among patients treated with nucleoside analogues alone, or in combination with antiretrovirals. These are severe and possibly fatal conditions.
Viread is the brand name for tenofovir disoproxil fumarate and is marketed by Gilead Sciences, Inc. of Foster City, CA.
October 4, 2001
ST. LOUIS (MD Consult) - NV Organon's NuvaRing female vaginal contraceptive product, an insertable ring that delivers estrogen and progestin over 3 weeks, has been cleared for sale by the the US Food and Drug Administration (FDA).
The FDA's action represents the agency's first clearance of a hormonal vaginal contraceptive ring, Organon said. The prescription device, which must be inserted on a monthly basis, is a 3-inch polymer ring containing etonogestrel and ethinyl estradiol. After insertion, the NuvaRing provides a continuous low dose of the active ingredients for 21 days.
Following the label instructions is necessary for maximum efficacy, and even under perfect conditions the device carries a 1% to 2% failure rate, the FDA said. This compares favorably with failure rates for other methods of hormonal birth control. If the ring has been out of the vagina for more than 3 hours, an additional method of contraception, such as male condom or spermicide, must be used until the ring has been back in place for 7 days, according to the FDA.
The NuvaRing may interfere with a diaphragm's correct placement and position, so the two devices should not be used together. Side effects of the NuvaRing include vaginal discharge, vaginal infection and irritation. As with oral contraceptives, NuvaRing may increase the chance of blood clots, myocardial infarction and stroke. The product is shouldn't be used by women with cardiovascular disease, blood clots or certain kinds of cancer. The label warns against the device's use by smokers.
October 15, 2001
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) granted marketing approval Oct. 12, 2001 to Britain's Shire Pharmaceuticals for Adderall XR, a once-daily version of the company's attention deficit/hyperactivity disorder (ADHD) drug Adderall (amphetamine, dextroamphetamine).
The FDA issued an approvable letter for the drug less than 2 months ago. Approval was based on results of two studies involving approximately 600 patients. The studies found ...
Adderall XR capsules contain a 50:50 ratio of immediate release and delayed release Microtol beads, resulting in 50 percent of the active ingredient being released immediately with the remaining 50 percent released mid-day. Shire said Adderall XR will be launched in the U.S. "imminently."
September 19, 2001
ST. LOUIS (MD Consult) - The U.S. Food and Drug Administration (FDA) has approved Amgen's Aranesp(darbepoetin alfa) for the treatment of anemia associated with chronic renal failure.
Aranesp is indicated for the treatment of anemia associated with chronic renal failure, including dialysis and non-dialysis patients. Chronic renal failure in its early stage of disease progression is referred to as chronic renal insufficiency (CRI), and over time progresses to end-stage renal disease (ESRD), the point at which patients require dialysis or kidney transplantation.
Aranesp can be administered less frequently than other anemia treatments, which simplifies anemia management for patients and healthcare providers. The recommended starting dose is 0.45 mcg/kg administered intravenously or subcutaneously once weekly.
Aranesp has been studied in 1,598 adults with chronic renal failure for a total of 942 patient-years in 12 clinical trials conducted at sites in North America, Europe, and Australia, according to the FDA. Clinical studies showed chronic renal failure patients receiving Aranesp consistently reached target hemoglobin (red blood cell) levels.
The studies showed Aranesp to be generally well-tolerated. Serious adverse events were associated with increases in hemoglobin greater than approximately 1.0 g/dL during any 2-week period in patients treated with Aranesp, including increased incidence of cardiac arrest, neurologic events (including seizures and stroke) and exacerbations of hypertension, congestive heart failure, vascular thrombosis/ischemia/infarction, acute myocardial infarction, and fluid overload/ edema were observed.
There have been rare reports of potentially serious allergic reactions including skin rash and urticaria associated with Aranesp. The most commonly reported side effects in Aranesp trials were infection, hypertension, hypotension, myalgia, headache, and diarrhea. Some of the adverse events reported are typically associated with chronic renal failure, or recognized complications of dialysis, and may not necessarily be attributable to Aranesp therapy.
Aranesp is contraindicated in patients with uncontrolled hypertension.
August 29, 2001
ST. LOUIS (MD Consult) - On August 29, the U.S. Food and Drug Administration approved a 200-mg form of Spectracef (cefditoren pivoxil), an oral anti-infective agent produced by TAP Pharmaceuticals.
According to the TAP Pharmaceuticals website, use of Spectracef is indicated for for the treatment of mild to moderate acute exacerbations of chronic bronchitis, pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections in adults and adolescents 12 years of age or older.
Side effects of Spectracef were mostly mild and self-limiting and included diarrhea, nausea, and vaginal moniliasis.
The use of Spectracef is contraindicated in patients that are allergic to cephalosporin antibiotics and in patients in whom carnitine deficiency is or may be a concern. Spectracef should also not be administered to patients with milk protein hypersensitivity.
August 20, 2001
ST. LOUIS (MD Consult) - On August 20, Novartis Pharmaceuticals received U.S. Food and Drug Administration (FDA) approval of Zometa (injectable zoledronic acid) for the treatment of hypercalcemia of malignancy (HCM).
According to Novartis, a statistically significant difference that favored Zometa over the standard current HCM treatment, injectable pamidronate disodium, was shown in clinical trials; this difference was demonstrated by the corrected serum calcium levels of patients after 10 days of treatment. Zometa also offers a more rapid infusion time than pamidronate disodium (15 minutes versus 2 to 24 hours).
HCM can be life-threatening, and it is the most common metabolic complication that occurs with cancer; the condition affects about 10 percent of cancer patients, and it usually occurs in the later stages of disease.
Novartis also states that Zometa should be used carefully in patients who have aspirin-sensitive asthma. Patients who are taking loop diuretics in addition to Zometa should be carefully monitored as well, because the combination could induce hypocalcemia. Zometa's use should also be limited in pregnant patients, and it is contraindicated in patients who are hypersensitive to zoledronic acid or other bisphosphonates.
August 14, 2001
ST. LOUIS (MD Consult) - On August 13, the U.S. Food and Drug Administration (FDA) approved Scios' intravenous Natrecor (nesiritide) for the treatment of acutely decompensated congestive heart failure (ADCHF). Scios plans to market this product for patients who have the condition and who also have shortness of breath while resting or with minimal activity.
Natrecor belongs to a new drug class called B-type natriuretic peptides; these drugs are synthetic versions of human hormones that are believed to relax cardiac vessels, which allows for greater blood flow. The drug is manufactured with the use of recombinant DNA technology.
According to Scios, Natrecor reduced pulmonary capillary wedge pressure in clinical trials, and it is currently the only drug approved for the treatment of ADCHF that has also improved patients' ability to breathe. The FDA's approval was based on data from several such trials, including the Vasodilatation in the Management of Acute Congestive Heart Failure Trial (VMAC). Side effects of Natrecor include headache and hypotension, and renal function may also be affected. Contraindications to the use of this drug include cardiogenic shock and a systolic blood pressure below 90 mm Hg.
Scios plans to have Natrecor available for sale by the end of August. It is the first new treatment for ADCHF to come out in 14 years.
August 09, 2001
ST. LOUIS (MD Consult) - On August 8, the U.S. Food and Drug Administration (FDA) approved Schering-Plough's Rebetol (ribavirin) injectable powder for use with Peg-Intron (pegylated interferon alpha-2b) capsules for the treatment of adult hepatitis C.
Rebetol had previously been approved for use with Intron-A, which is also a product of Schering-Plough, and the drugs were packaged together. Peg-Intron is a longer-acting form of Intron-A. Last month, following FDA approval, Rebetol was "unbundled" from Intron-A for sale in a separate package; this made its labeling for use with Peg-Intron more feasible. Schering-Plough plans to start selling the unbundled Rebetol this fall.
Studies of Peg-Intron and Rebetol have shown that this combination is slightly more effective than Intron-A and Rebetol. According to the FDA, at 24 weeks, 52 percent of patients taking the Peg-Intron/Rebetol combination had levels of hepatitis C that were undetectable, whereas 46 percent who were taking the Intron-A/Rebetol combination had comparable levels. In patients who had difficult-to-treat strains of the virus, the response rate was 41 percent in those taking Peg-Intron and Rebetol and 33 percent in those taking Intron-A and Rebetol.
According to the Centers for Disease Control and Prevention, about 4 million Americans currently have hepatitis C. The newly approved combination of drugs will allow for once-a-week dosing; current standard therapy requires the drugs to be taken three times a week.
May 22, 2001
ST. LOUIS (MD Consult) - Insulin glargine (Lantus)--the only diabetes medication to provide 24-hour glucose-lowering activity with once-daily administration--has received its U.S. launch, according to a May 22 announcement by drugmaker Aventis.
The new insulin analog can be given by once-daily injection at bedtime to adults and children over age 6 with type 1 diabetes, or in adults who require long-acting insulin to control type 2 diabetes. Lantus is absorbed more slowly than other forms of basal insulin, providing a relatively constant concentration/time profile.
FDA approval was based on six open, randomized trials comparing once-daily Lantus with once- or twice-daily neutral protamine Hagedorn (NPH) insulin in more than 4,000 diabetic patients. Given in combination with the same oral hypoglycemic agents or short-acting insulins, the two basal insulins provided similar safety and efficacy.
Lantus is expected to have a major impact on the market for diabetes medications. In Germany, where Lantus was launched last year, it accounts for 28% of the basal insulin market. Lantus is available for prescription in U.S. pharmacies now, according to the Aventis announcement.
May 10, 2001
ST. LOUIS (MD Consult) - After a review period of less than 3 months, the FDA has approved imatinib mesylate (STI-571) as an oral treatment for chronic myeloid leukemia.
The new drug will be marketed as Gleevec by Novartis Pharmaceuticals Corp.
Imatinib is approved for treatment in three phases of CML: myeloid blast crisis, accelerated phase, or chronic phase after failed interferon therapy. In clinical trials including approximately 1,000 patients, the drug was shown to significantly reduce the number of cancerous cells in bone marrow and blood.
Imatinib--a specific inhibitor of the enzyme created by the "Philadelphia" chromosome translocation that causes CML--works by blocking rapid growth of white blood cells.
Imatinib was approved under the FDA's orphan drug program. Accelerated approval means that the drug is approved for its effect on "a surrogate endpoint that is reasonably likely to predict a real clinical benefit." Its effects on survival and other long-term outcomes are unknown; Novartis is recruiting patients for clinical follow-up studies.
Imatinib's approval has received extensive media attention as the fastest ever by the FDA, and as an important milestone in molecular targeting in cancer treatment. Novartis plans to make the drug available by the end of May. The FDA's Center for Drug Evaluation and Research offers additional information online at http://www.fda.gov/cder/drug/infopage/gleevec/.
May 7, 2001
ST. LOUIS (MD Consult) - The FDA has approved almotriptan malate for the acute treatment of migraine with or without aura.
The product will be marketed as Axert by Pharmacia Corp.
Approval is based on placebo-controlled trials demonstrating the safety and effectiveness of almotriptan. Two hours after treatment, patients taking an almotriptan dose of 6.25 or 12.5 mg were significantly more likely to have a response--defined as mild or no pain--than those taking placebo.
Almotriptan had a low rate of side effects, similar to that or placebo. It also has a low percentage of side effects previously associated with other triptan drugs, including chest discomfort and pain. Almotriptan should not be used in patients with ischemic or vasospastic coronary artery disease.
Almotriptan is not indicated for prophylactic treatment of migraine, and its use in patients with cluster headache has not been evaluated.
Pharmacia offers further information on almotriptan online at http://www.axert.com or by telephone at 800-253-8600, ext 3-8244.
May 8, 2001
ST. LOUIS (MD Consult) - The FDA has approved the humanized monoclonal antibody alemtuzumab for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) that has failed to respond to alkylating agents and fludarabine.
The new product, developed by a joint venture of Millennium Pharmaceuticals, Inc., and ILEX Oncology, Inc., will marketed by Berlex Laboratories, Inc., as Campath.
In the latest and largest clinical trial to date, alemtuzumab achieved an overall response rate of 33% in patients with refractory B-CLL, most of whom had advanced disease. Median duration of response was 7 months.
Prescribers are warned that alemtuzumab treatment is associated with serious risks. Mortality in the latest clinical trial was 30%, with one-half of the deaths being treatment-related. Treatment carries the potential for serious and potentially fatal hematologic toxicity and infections, and a risk of serious infusion reactions. Alemtuzumab is to be given "under the supervision of a physician experienced in the use of antineoplastic agents."
The approval provides a new alternative for patients with refractory B-CLL, for whom no other approved options are available. Alemtuzumab's mechanism of action appears to involve targeting of the CD52+ antigen, which appears on malignant lymphocytes in patients with B-CLL.
Accelerated approval of alemtuzumab was recommended by the Oncologic Drugs Advisory Committee to the FDA in December, 2000. Berlex plans to have the product available in early June. Prescribing information is available online at www.berlex.com or by telephone at 1-888-BERLEX-4.
April 20, 2001
ST. LOUIS (MD Consult) - The FDA has approved a new albuterol metered-dose inhaler (MDI) using a non-chlorofluorocarbon (CFC) propellant.
The new product, albuterol sulfate HFA, will be marketed as Ventolin HFA by GlaxoSmithKline. It is the second non-CFC albuterol inhaler on the market. The first, Proventil HFA, was approved in 1996. Glaxo already markets a CFC-containing version of Ventolin.
The new inhaler uses hydrofluoroalkane as an alternative to CFC propellant. The commercial use of CFC propellants is banned in the United States under the U. S. Clean Air Act. "Medical essential-use" products are exempted from the ban. However, the FDA plans to phase out CFC-based MDIs as sufficient alternatives become available.
According to an FDA Talk Paper dated April 20, "the removal of albuterol CFC MDIs would take place after there is a complete assessment of the continuing medical need...given at least two acceptable HFA alternatives." However, the FDA emphasizes that it will consider input from physicians, patients, and other members of the public implementing any ban on CFC-containing MDIs.
April 2, 2001
ST. LOUIS (MD Consult) - The FDA announced last month its approval of the oral medication valganciclovir for treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. The product will be marketed by Hoffman-La Roche, Inc., as Valcyte.
Valganciclovir is an oral prodrug of ganciclovir, currently the most widely used treatment for CMV retinitis. Coming after a priority review by the FDA, the approval clears the way for valganciclovir as the first oral treatment for induction and maintenance therapy of CMV retinitis, a potentially blinding complication of AIDS.
Approval was based on a randomized trial of 160 AIDS patients with CMV retinitis. After 4 weeks of treatment, those receiving oral valganciclovir were no more likely to have CMV progression than those receiving IV ganciclovir, the standard treatment.
Roche recommends a 21-day course of valganciclovir, two 450 mg tablets twice daily, as induction therapy for active CMV retinitis. The recommended dose for maintenance therapy is two 450 mg tablets once daily. Pharmacokinetic data suggest that oral valganciclovir has 10 times greater bioavailability of ganciclovir, compared with the oral formulation of ganciclovir.
Valganciclovir, which is metabolized to ganciclovir, carries a significant rate of adverse effects. Among other safety warnings, the manufacturer emphasizes that valganciclovir tablets cannot simply be substituted for the same number of ganciclovir capsules.
The new approval will allow many AIDS patients to switch from IV to oral therapy. The manufacturer plans to make valganciclovir available sometime in late Spring 2001. It is also studying the drug for use in CMV prophylaxis after solid organ transplantation.
March 19, 2001
ST. LOUIS (MD Consult) - The Food and Drug Administration (FDA) announced the approval of two new drugs to treat the elevated intraocular pressure which is often associated with glaucoma - Lumigan (bimatoprost ophthalmic solution) 0.03% and Travatan (travoprost ophthalmic solution) 0.004%. They will provide additional alternatives for the reduction of intraocular pressure in patients who are intolerant of other intraoular lowering medications, or in patients who have had insufficient responses to other intraocular pressure lowering medications. Many of these patients might otherwise need surgery for management of their glaucoma.
Glaucoma, a leading cause of irreversible blindness in the world, is the second most common cause of blindness in the United States. Glaucoma represents a family of diseases commonly associated with optic nerve damage and visual field changes (a narrowing of the eyes' usual scope of vision). Elevated intraocular pressure is a primary risk factor for glaucoma.
"Glaucoma is a serious eye disease affecting some two million older Americans," said Health and Human Services Secretary Tommy G. Thompson. "Early detection of glaucoma and management of raised eye pressure can usually prevent vision loss. These new drugs provide additional treatment alternatives to preserve vision as well as preserve an individual's quality of life."
In separate clinical trials, Lumigan and Travatan had similar effects in lowering intraocular pressure. Higher intraocular pressures greatly increase the risk of optic nerve damage and vision loss.
Side effects associated with Lumigan and Travatan may include gradual darkening of eye color, darkening of eyelid skin, and increased thickness, number, and darkness of eyelashes.
The availability of multiple medical alternatives provides physicians with additional treatment options for their patients whose glaucoma is difficult-to-manage.
Lumigan will be marketed by Allergan, Inc. of Irvine, California. Travatan will be marketed by Alcon Universal, Ltd of Fort Worth, Texas.
February 16, 2001
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) announced on February 16, 2001 the approval of OraPharma's new treatment for periodontal disease in patients who have undergone scaling or root planning. The treatment, Arestin, is expected to be launched in early April.
Fifty-three million Americans suffer from periodontal disease, with most not receiving treatment. Periodontal disease involves destruction of gum tissue and bone, creating pockets of plaque and bacteria. Investigations are showing a systemic link between periodontal disease and other health conditions such as coronary heart disease; stroke; diabetes; and pre-term, low infant birth weight.
Treatment for the disease involves patented microsphere technology that delivers the antibiotic minocycline beneath the gum and directly at the point of infection after scaling or root planning has been performed. Arestin is one of four drugs approved by the FDA to dispense this antibiotic therapy. The others include Atridox ($160 per year of treatment), PerioChip ($280 per year), and PerioStat ($260 per year). Arestin has been touted as a lower-cost alternative ($150 per year) that does not require mixing, refrigeration, or extended patient chair time to apply.
According to Ray C. Williams, D.M.D., Chairman of Periodontology at the University of North Carolina at Chapel Hill, "Arestin...allows us to treat numerous sites within the mouth in a matter of minutes. It is essentially a whole mouth treatment that helps to restore patients to good oral health."
February 16, 2001
ST. LOUIS (MD Consult) - As announced in a press release from Novartis Pharmaceuticals Corporation, Foradil aerolizer (formoterol fumarate inhalation powder), a selective beta2-agonist, was approved by the U.S. Food and Drug Administration (FDA) on February 16th.
Foradil has been approved for maintenance treatment of asthma and the prevention of bronchospasm in adults and children 5 years of age and older with "reversible obstructive airways disease, including patients with symptoms of nocturnal asthma who require regular treatment with inhaled, short-acting beta2-agonists." Foradil has also been approved for the acute prevention of exercise-induced bronchospasm in adults and children 12 years of age and older, when administered on a PRN basis.
According to Novartis, Foradil capsules are easily administered via a new device called the "Aerolizer Inhaler." This inhaler can be visually inspected so patients can confirm they have received the full dose of medicine. In addition, the inhaler makes a whirring noise to indicate that the drug is being dispensed.
Many clinical trials were conducted on Foradil. Two randomized, double-blind, multicenter studies involving patients with mild to moderate asthma, aged 12 years and older, demonstrated that 12mcg of Foradil given twice daily provided significant bronchodilation throughout a 12-hour observation. The research also showed that, as compared with a placebo, Foradil provides nighttime protection from asthma symptoms and resulted in less awakenings and use of rescue medication.
Another clinical trial examined the use of Foradil in pediatric patients aged 5 to 12 years old. This trial showed that the same dose of Foradil (12mcg BID) "produced clinically and statistically greater bronchodilation than placebo." Finally, two additional randomized, single-dose, double-blind clinical trials in patients 12 years and older studied the effects of Foradil on exercise-induced bronchospasm. The results of this these trials demonstrated that 12mcg of Foradil prevented exercise-induced bronchospasm for up to 12 hours after dosing "in the vast majority of patients."
Adverse reactions to Foradil were similar to those experienced with the use of other selective beta2-agonists, including tachycardia, tremors, dizziness, abdominal pain, and insomnia.
Novartis notes that "Foradil aerolizer is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting beta2-agonists...and has not been studied as a rescue medication and, therefore, should not be used for that indication."
February 5, 2001
ST. LOUIS (MD Consult) - On February 5th, the U.S. Food and Drug Administration (FDA) approved Pfizer's Zeldox (ziprasidone), which is used in the treatment of schizophrenia.
Ziprasidone is both a serotonin and dopamine antagonist that, according to a press release from the drug's manufacturer, "is effective across its dose range in treating the positive and negative symptoms associated with schizophrenia." These symptoms include social withdrawal, lack of motivation, visual and auditory hallucinations, and delusions.
Short-term, placebo-controlled clinical trials were conducted to evaluate the effectiveness of ziprasidone in treating both the positive and negative symptoms of schizophrenia. Ziprasidone was reported to have better symptom control than placebo. In addition, a yearlong placebo-controlled study was undertaken in stable, chronic inpatients; Ziprasidone proved superior in delaying the rate of and time to a relapse.
Zeldox is reported to have a minimal effect on a patient's weight. Common side effects of the drug are headache, somnolence, nausea, constipation, dyspepsia, abnormal movements, and respiratory disorders. Most side effects were of a mild to moderate severity. Furthermore, Zeldox may also be associated with a slight prolongation in the QTc interval of a patient's electrocardiogram. This side effect has been well documented in the clinical trials conducted on ziprasidone and is shown on the product's label. According to the FDA's product labeling, prescribing physicians should "use their best judgment, based on the overall status of the patient, as to whether ziprasidone or another antipsychotic agent be used first."
Zeldox is expected to be introduced in the United States in March. The drug should be available in 20, 40, 60, and 80-mg capsules.
February 1, 2001
ST. LOUIS (MD Consult) - On February 1st, Watson Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved the company's generic formulation of Purdue Frederick's MS Contin controlled-release tablets (100 mg).
The drug is indicated for the relief of moderate to severe pain.
January 31, 2001
ST. LOUIS (MD Consult) - The U.S. Food and Drug Administration (FDA) has granted approval to Smith & Nephew's Supartz (sodium hyaluronate), a new treatment for osteoarthritis (OA) of the knee. According to the FDA, it is indicated for the treatment of pain in OA of the knee in patients who have failed to respond adequately to conservative, non-pharmacologic therapy and simple analgesics. The drug works by supplementing the body's natural synovial fluid to provide long-term pain relief for those patients affected by OA.
According to a press release from the drug company, Supartz is manufactured by Seikagaku Corporation of Japan. The drug has been the subject of 18 clinical studies that involved more than 10,700 patients, including patients of a Japanese post-market drug surveillance. The product will be co-labeled with both the Smith & Nephew and Seikagaku names.
As reported in the labeling information for Supartz, the drug is administered by intra-articular injection once a week for a total of five injections. The effectiveness of a treatment cycle of less than five injections has not yet been established. In addition, the safety and effectiveness for use of the drug in joints other than the knee has not been established.
Supartz is contraindicated in patients with known hypersensitivity to sodium hyaluronate preparations. The most common adverse events reported were arthralgia, arthropathy/arthrosis/arthritis, back pain, pain of non-specific origin, injection site reaction, headache, and pain at the site of injection. Five allergic reactions were reported.
January 29, 2001
ST. LOUIS (MD Consult) - The U.S. Food and Drug Administration (FDA) announced on January 29th that it has approved Cancidas (caspofungin acetate) Intravenous Infusion, a treatment for invasive aspergillosis in patients who do not respond or cannot tolerate standard antifungal therapies, amphoteracin B, lipid formulations of amphoteracin B, and/or itraconazole. Cancidas is manufactured by Merck and Co., Inc.
Cancidas is the first approved drug for a new class of antifungal medications called echinocandins or glucan synthesis inhibitors. This is the first new class of antifungal agents to be introduced in more than a decade.
According to an FDA Talk Paper, the approval of the drug was based on a "small, multi-center, open-label, non-comparative study designed to evaluate the safety, tolerability, and efficacy of Cancidas." The study looked at 69 immunocompromised patients who had invasive aspergillosis and were either unresponsive to or intolerant of other antifungal therapies. The approval decision also took into account the efficacy information obtained in preclinical and supportive clinical studies.
Forty-one percent of patients (26 out of 63) who had received at least a single dose of Cancidas had a favorable response to treatment. In addition, of the patients who received more than seven days of treatment, 50 percent (26 out of 52) had a favorable response. Response to treatment was evaluated by an independent panel of experts.
Cancidas has not been studied as an initial therapy for the treatment of invasive aspergillosis and is not recommended. Also, the efficacy of Cancidas in combination with other antifungal medications has not been evaluated and is also not recommended. Finally, the company does not recommend the use of Cancidas with cyclosporine "unless the potential benefit outweighs the potential risk to the patient." Cancidas is contraindicated in any patient with a known hypersensitivity to any component in the product.
According to the drug's prescribing information, the recommended dosage of Cancidas is a single 70mg loading dose administered on day one, followed by a 50mg dose once daily thereafter. The most common clinical side effects reported included fever, complications in the infusion vein, headache, nausea, vomiting, rash, and skin flushing. One case of anaphylaxis was reported.
January 23, 2001
ST. LOUIS (MD Consult) - The FDA has announced its approval of peginterferon alfa-2b as an injectable, once-weekly treatment for patients with chronic hepatitis C.
The product --the first pegylated interferon available in the U.S.-- will be marketed as Peg-Intron by Schering-Plough. Peg-Intron is indicated for use in adult patients with chronic, compensated hepatitis C who have not previously received alpha-interferon.
Approval was based on a randomized, controlled trial of 1,219 patients with chronic hepatitis C. Patients receiving a 1.0 mcg/kg dose of Peg-Intron had 24 percent response rate --defined as a complete virologic response with normalization of alanine aminotransferase-- compared with 12 percent for patients receiving standard treatment with recombinant interferon alfa-2b (Intron-A).
Adverse events were common with both treatments, with an incidence of about 12 percent. In the Peg-Intron group, flu-like symptoms occurred in about 50 percent of patients, injection site symptoms in 47 percent, and depression in 29 percent. The manufacturer warns that Peg-Intron --like other alpha-interferons-- may cause or aggravate serious neuropsychiatric, autoimmune, ischemic, and infectious disorders.
The new product uses patented pegylation technology to optimize the balance between antiviral activity and elimination half-life. It is hoped that the once-weekly dosing of Peg-Intron will enhance compliance, and thus improve the outcomes for patients with chronic hepatitis C. Peg-Intron should be given on the same day of every week. It may be self-administered by patients.
The new product is seen as a new alternative to combination therapy with alpha interferon and ribavarin. Schering-Plough plans to have Peg-Intron on the market in February.
January 11, 2001
ST. LOUIS (MD Consult) - Earlier this month, the FDA announced its approval of letrozole as a new frontline treatment for advanced breast cancer in postmenopausal women. The new medication will be marketed as Femara by Novartis Oncology.
Letrozole is indicated for use in the initial treatment of locally advanced or metastatic, hormone receptor-positive or -unknown breast cancer in postmenopausal women. This means it will be appropriate for most postmenopausal women with advanced breast cancer.
Approval was based on a phase III randomized trial comparing letrozole with tamoxifen, which has been the standard frontline therapy. In a sample of 900 women with advanced breast cancer, mean time to progression was 9.4 months with letrozole vs 6.0 months with tamoxifen. The overall tumor response rate was 30% with letrozole vs 20% with tamoxifen. Forty-nine percent of women in the letrozole group benefited from treatment, compared with 38% in the tamoxifen group.
In another study, letrozole also performed better than tamoxifen as preoperative treatment to reduce the size of tumors before breast-conserving surgery.
The two treatments were equally well tolerated. Adverse effects included a 20% rate of bone pain, an 18% rate of hot flushes, and a 17% rate of back pain. Letrozole should not be used in patients with known hypersensitivity.
The approval came after priority review by the FDA and a unanimous recommendation from the Agency's Oncologic Drugs Advisory Committee. Letrozole was approved as a second-line therapy for advanced, hormone-dependent breast cancers in 1997.
Letrozole appears to represent an important advance in hormonal therapy for postmenopausal women with advanced breast cancer.
January 2, 2001
ST. LOUIS (MD Consult) - Earlier this month, the FDA announced its approval of the tumor necrosis factor (TNF)-blocking agent infliximab, in combination with methotrexate, as the first medication to reduce progressive joint damage in patients with rheumatoid arthritis (RA). Infliximab is marketed as Remicade by Centocor, Inc., a subsidiary of Johnson & Johnson.
In clinical trials, RA patients receiving infliximab plus methotrexate had significantly less progression in radiographic joint damage scores, compared with controls receiving placebo plus methotrexate. Overall median change on the 5-point van der Heijde modified sharp scoring system was 0.0 in the active treatment group, compared with 4.0 in the control group. Fifty-three percent of infliximab-treated patients had no progression.
Infliximab plus methotrexate also provided greater reductions in arthritis-related pain and stiffness and in the swollen and tender joint count.
The TNF-blocking agent was well tolerated. Side effects included upper respiratory infections, headache, and mild infusion reactions. There was no increase in the rate of serious infections or other adverse events, compared with patients receiving methotrexate plus placebo.
Infliximab should not be used in patients with chronic infections or a history of recurrent infections. Last month, a European report cited several cases of tuberculosis in patients receiving infliximab.
The approval represents a new indication for infliximab, which was initially approved in 1998 for short-term treatment of Crohn's disease. In 1999, the combination of infliximab and methotrexate was approved for RA patients with an inadequate response to methotrexate alone.
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