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FDA denies approval of once-weekly exenatide, does not request new trials
Monday, March 15 2010 | Comments
What's This?
Amylin Pharmaceuticals Inc., Eli Lilly and Co. and Alkermes Inc. received a complete response letter from the Food and Drug Administration regarding their New Drug Application for a once-weekly, extended-release formulation of the diabetes drug Byetta (exenatide).The FDA did not ask the firms to conduct any additional trials of the drug, which has a proposed brand name of Bydureon.
However, the agency requested that the companies finalize information to be included on the drug's label and create a risk evaluation and mitigation strategy. It also asked for clarification of existing manufacturing processes. These requests were not related to observations made during a December 2009 preapproval inspection of an Ohio manufacturing facility; the companies said all of those issues have been addressed.
Amylin said the firms are "working diligently" to submit a response to the FDA in the next few weeks.
The NDA for Bydureon was submitted last May and accepted by the FDA in July. Bydureon uses a technology developed by Alkermes that encapsulates exenatide in polymer-based microspheres that degrade slowly in the body while providing continuous therapeutic levels.
Shares of Amylin closed at $23.50, up $3.24, or 16 percent, while shares of Alkermes closed at $14.01, up $1.80, or 14.7 percent, both in heavy volume on the Nasdaq.
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