New FDA Approvals
These drugs were recently approved by the FDA:
• Entecavir (Baraclude) by Bristol-Myers Squibb Co. The FDA has announced the approval of entecavir (Baraclude) tablets and oral solution for the treatment of chronic hepatitis B in adults. Entecavir slows the progression of chronic hepatitis B virus (HBV) by interfering with viral reproduction.
The FDA based its approval of entecavir on the results of three studies in which entecavir was compared to lamivudine. In all three clinical studies, patients treated with entecavir showed significant improvement in the liver inflammation caused by HBV and an improvement in the degree of liver fibrosis. In addition, a higher percentage of patients treated with entecavir showed significant improvement compared to lamivudine.
The major adverse events associated with the use of entecavir were of the type typically seen with HBV therapy. They include severe, acute exacerbation of hepatitis B after discontinuation of entecavir, headache, abdominal pain, diarrhea, fatigue, and dizziness. The labeling for entecavir states that patients who discontinue entecavir should be monitored at repeated intervals over a period of time for liver function. Bristol-Myers Squibb Co. has committed to conducting a large post-marketing study of entecavir to evaluate the risks of cancers and liver-related complications.
• A new indication for ropinirole (Requip) by GlaxoSmithKline. The FDA has approved ropinirole (Requip) to treat moderate-to-severe restless legs syndrome (RLS). The drug was first approved for Parkinson’s disease in 1997.
Ropinirole was found to be effective for RLS in three randomized, double-blind placebo controlled studies in adults diagnosed with moderate-to-severe RLS. The studies measured effectiveness of the drug using the International Restless Leg Syndrome scale, a patient-rated scale that measures different aspects of RLS including severity of muscle movement and discomfort, sleep disturbance, mood, and overall effect on quality of life. The Clinical Global Impression-Global Improvement scale also was used. This is an investigator-rated scoring of improvement following treatment. All three studies demonstrated a statistically significant difference between the treatment group receiving Requip and the group receiving placebo.
Common side effects reported in clinical trials include nausea, headache, and vomiting. The label for the drug also will include a caution that ropinirole has been associated with sedating effects, including somnolence, and the possibility of falling asleep while engaged in activities of daily living, including operation of a motor vehicle. Syncope or symptomatic hypotension may occur, particularly during initial treatment or dosing.
• Exenatide (Byetta) injection by Eli Lilly. Amylin Pharmaceuticals and Eli Lilly and Co. have announced that the FDA has approved exenatide (Byetta) injection as adjunctive therapy to improve blood sugar control in patients with Type 2 diabetes who have not achieved adequate control on metformin and/or a sulfonylurea. It is the first in a new class of medicines known as incretin mimetics and became available to pharmacies June 1.
In addition to approving exenatide for use as an adjunct to existing oral medicines, the FDA also stated that exenatide is approvable as a monotherapy for patients with Type 2 diabetes. Any additional data submitted to support a monotherapy indication is expected to receive a six-month review.
Exenatide is formulated for self-administration as a fixed-dose, subcutaneous injection given prior to the morning and evening meals. It will be made available in both a 5-mcg dose and a 10-mcg dose prefilled pen-injector device.
In three 30-week controlled trials, adverse events associated with exenatide were generally mild to moderate in intensity. The most frequently reported adverse event was mild-to-moderate, dose-dependent nausea. With continued therapy in most patients who initially experienced nausea, the frequency and severity decreased over time. Patients also should be advised that treatment with exenatide may result in a reduction in appetite, food intake, and/or body weight and that there is no need to modify the dosing regimen due to such effects.
Entecavir (Baraclude) by Bristol-Myers Squibb Co. The FDA has announced the approval of entecavir (Baraclude) tablets and oral solution for the treatment of chronic hepatitis B in adults. Entecavir slows the progression of chronic hepatitis B virus (HBV) by interfering with viral reproduction.Subscribe Now for Access
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