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news.Amylin Pharmaceuticals, Eli Lilly and Alkermes have stated that the FDA has classified the Bydureon (exenatide for extended-release injectable suspension) complete response as a class 2 resubmission and assigned a new prescription drug user fee act (PDUFA) action date of October 22, 2010.
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Amylin Pharmaceuticals, Eli Lilly and Alkermes have claimed that Bydureon is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose.
Bydureon is the active ingredient in Byetta, which has been available in the US since June 2005 and is used in approximately 60 countries worldwide to improve glycemic control in adults with type 2 diabetes.
The companies said that the new drug application (NDA) for Bydureon was submitted in May 2009 and was based on data from the Duration clinical trial program, as well as more than seven years of clinical experience with Byetta (exenatide) injection. The agency issued a complete response letter to the companies in March 2010 and the companies responded to that letter in April 2010.
Orville Kolterman, senior vice president of research and development of Amylin Pharmaceuticals, said: “If approved, Bydureon is expected to be the first once-weekly treatment for type 2 diabetes, and we are committed to making this therapeutic option available to patients as soon as possible. We will continue to work closely with the agency through this final stage of the review process.”