Alkermes drug application put on ice
The snow storms that slammed the mid-Atlantic region this month shut down government agencies around Washington, D.C., long enough for the U.S. Food and Drug Administration to delay its review of Alkermes Inc.’s new drug application for diabetes therapy exenatide.
Waltham, Mass.-based Alkermes (Nasdaq: ALKS), which co-developed the drug with Amylin Pharmaceuticals Inc. and Eli Lilly and Co., said the FDA is adding five days to its review of exenatide, moving its action date out to March 12 cash advance payday loan.
Exenatide is intended to be an extended-release medication for Type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. The application for exenatide’s once-weekly formula was submitted in May 2009 and accepted by the FDA in July 2009.