New FDA Approvals
May 1, 2005 4 minutes read
These drugs were recently approved by the FDA:
• Pramlintide acetate (Symlin) injection by Amylin Pharmaceuticals. The FDA has approved pramlintide acetate, an injectable medicine to control blood sugar for adults with Type 1 and Type 2 diabetes. Pramlintide acetate is to be used in addition to insulin therapy in patients who cannot achieve adequate control of their blood sugars on intensive insulin therapy alone.
Pramlintide acetate will be the only therapy for the treatment of Type 1 diabetes other than insulin. Patients with Type 2 diabetes have several other types of oral therapies available.
The safety and efficacy of pramlintide acetate were studied in approximately 5,000 patients. Overall, pramlintide acetate therapy was associated, in patients with both types of diabetes, with improvements in the control of blood glucose and with weight loss.
Pramlintide acetate is to be used only in combination with insulin to help lower blood sugar during the three hours after meals. Pramlintide acetate will have a Medication Guide (FDA-approved patient labeling) and a Risk Minimization Action Plan (RiskMAP) due to three areas of concern. First, the principal risk associated with pramlintide acetate therapy is hypoglycemia, and this risk is greatest in patients with Type 1 diabetes and in patients with gastroparesis. Second, the potential for medication errors, specifically mixing of pramlintide acetate with insulin in the same syringe, which can alter the activity of the insulin, is addressed in the Medication Guide and in physician labeling. Finally, the potential for off-label use in patients where the risk-benefit profile has not been characterized or demonstrated is also a concern and will be monitored by the sponsor.
Pramlintide acetate should not be used if patients cannot tell when their blood sugar is low, have gastroparesis, or are allergic to pramlintide acetate, metacresol, D-mannitol, acetic acid, or sodium acetate.
Side effects associated with pramlintide acetate include but are not limited to nausea, vomiting, abdominal pain, headache, fatigue, and dizziness.
Pramlintide acetate has not been evaluated in the pediatric population.
• Entecavir (Baraclude) by Bristol-Myers Squibb Co. The FDA has approved entecavir (Baraclude) tablets and oral solution for the treatment of chronic hepatitis B in adults. Entecavir slows the progression of chronic hepatitis B 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 hepatitis B virus (HBV) and an improvement in the degree of liver fibrosis (scarring). 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.
• Ibandronate sodium (Boniva) 150 mg tablets by Roche and GlaxoSmithKline. The FDA has approved once-monthly oral ibandronate sodium (Boniva) 150 mg tablets, the first once-a-month medicine for the treatment of postmenopausal osteoporosis. With once-monthly ibandronate sodium, patients would take 12 tablets a year vs. 52 required with current weekly bisphosphonate treatments.
Ibandronate sodium 150 mg once-monthly and ibandronate sodium 2.5 mg daily are indicated for the treatment and prevention of postmenopausal osteoporosis. Once-monthly ibandronate sodium was expected to be available by prescription in U.S. pharmacies in April.
Daily ibandronate sodium (2.5 mg) was approved for the treatment and prevention of osteoporosis based on studies showing that, over three years, it significantly reduced the risk of new vertebral fractures in women with postmenopausal osteoporosis and increased bone mineral density in postmenopausal women without osteoporosis. Once-monthly oral ibandronate sodium (150 mg) was approved based on results from the MOBILE study (Monthly Oral iBandronate In LadiEs), a randomized, double-blind, multinational, noninferiority trial in 1,602 women with postmenopausal osteoporosis.
Once-monthly ibandronate sodium is a small, film-coated, easy-to-swallow tablet dosed at 150 mg. Patients should take ibandronate sodium with plain water on an empty stomach upon rising in the morning. They should remain upright and avoid food, drink, and other medications for at least 60 minutes.
Patients who take ibandronate sodium are eligible to sign up for MyBONIVA, a patient support program designed to help enhance compliance (taking therapy as directed) and persistence (staying on therapy) with this unique once-monthly regimen. For more information on this program, call (800)-4-BONIVA.
• New indication for temozolomide (Temodar) by Schering-Plough Corp. The FDA has approved a new indication for temozolomide. The drug, used concurrently with radiotherapy and as maintenance therapy after radiotherapy, can extend the lives of adult patients newly diagnosed with glioblastoma multiforme (GBM).
The new approval of temozolomide for GBM was based on efficacy and safety data from a large randomized controlled study conducted by the European Organization for Research and Treatment of Cancer (EORTC) in patients with newly diagnosed GBP. Patients were randomized to treatment with radiation alone or to treatment with radiotherapy plus temozolomide. In the multicenter trial of 573 patients, median survival was improved by 2½ months in the temozolomide group, a significant benefit. The median survival was 14.6 months with radiotherapy plus temozolomide and 12.1 months with radiotherapy alone.
Temozolomide was previously granted accelerated approval in 1999 for the treatment of adult patients with anaplastic astrocytoma in relapse after chemotherapy with nitrosourea and procarbazine. The anaplastic astrocytoma indication now is approved under traditional procedures, and the accelerated approval requirements no longer apply.
Side effects for temozolomide reported include nausea, vomiting, headaches, fatigue, and anorexia. Preventive treatment for Pneumocystis carinii pneumonia is required when temozolomide is administered with radiotherapy.
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