Enzon Pharmaceuticals announced that FDA has granted full approval for DepoCyt (cytarabine liposome injection) for the treatment of patients with lymphomatous meningitis, a life-threatening complication of lymphoma. DepoCyt was originally approved under the Accelerated Approval regulations of Subpart H of the Food, Drug and Cosmetic Act, based on a preliminary demonstration of an increased complete response rate compared to unencapsulated cytarabine. The full approval was based on findings from two randomized controlled clinical trials that included over 200 patients with neoplastic meningitis related to solid tumors, lymphoma or leukemia. The first study demonstrated that more patients with lymphomatous meningitis treated with DepoCyt showed an absence of neurological progression of the disease. The second study showed an increase in complete cytologic responses among patients treated with DepoCyt, as defined by a clearing of malignant cells in the cerebrospinal fluid. DepoCyt is manufactured by SkyePharma.
Abbott submitted a New Drug Application to the FDA for Simcor, a fixed-dose combination of Niaspan (extended-release niacin) and simvastatin, the generic version of Merck’s Zocor. This product seeks to target multiple lipid parameters in a single pill. Niaspan and simvastatin, are two widely prescribed medications for treating cholesterol. Niaspan is used to raise HDL "good" cholesterol levels, and simvastatin is effective in reducing LDL "bad" cholesterol levels.
Wyeth said the FDA will extend its review of Pristiq (desvenlafaxine succinate) to treat menopause symptoms until late July, several months later than expected. The FDA was previously scheduled to issue a decision on Pristiq this week. Wyeth said during an earnings call with analysts and investors that the FDA postponed its decision on the drug so that regulators could review additional drug data submitted by Wyeth. The new data show that lowering Pristiq’s dosage lessens side effects, including nausea, which could make the drug safer and more appealing to patients, Wyeth VP Joe Mahady said during the call. Wyeth is also hoping to get FDA approval to market Pristiq as a treatment for depression in older women. But the FDA’s review of Pristiq for depression has also been delayed. If approved, marketing of Pristiq for depression won’t happen at least until the first part of 2008, Wyeth said.
An FDA advisory panel voted in favor of approving Bristol-Myers Squibb’s blockbuster blood pressure drug Avalide for wider use in patients not previously treated for high blood pressure. Avalide, part of the larger Avalide-Avapro franchise that earned $1.1 billion in 2006 global sales, is currently only approved for hypertension patients who have failed other types of treatment. The advisory panel’s vote will be taken into consideration by FDA regulators when they decide at a later date whether to approve the drug. Analysts predict approval won’t have too much of an impact on company sales since the drug is already prescribed off-label for untreated patients.
Alpharma’s application for Kadian 10 mg strength capsule has received approval. The company expects to launch this new dosage strength in 2007. This is the second FDA approval for a Kadian line extension in 2007. In March 2007, the company received FDA approval for a 200 mg dosage strength which was launched in April. Kadian is Alpharma's branded extended release morphine sulfate product and is currently marketed in 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg and 200 mg dosage strengths.