SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., Oct. 19 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM) (exenatide extended-release for injectable suspension).
In the complete response letter the FDA requested a thorough QT (tQT) study with exposures of exenatide higher than typical therapeutic levels of BYDUREON. The tQT protocol will be agreed to by the FDA prior to study initiation. Additionally, the FDA has now requested the results of the DURATION-5 study to evaluate the efficacy, and the labeling of the safety and effectiveness, of the commercial formulation of BYDUREON. This letter did not cite any manufacturing processes referenced in the FDA's March 15 complete response letter. REMS and product labeling discussions will continue following submission of the additional data.
The companies' goal is to submit their reply to the complete response letter by the end of 2011, pending discussions with the FDA. Based on the requirements for additional data, this will likely be considered a Class 2 resubmission requiring a six-month review.
Wednesday, October 20, 2010
Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON(TM) - Health News - redOrbit
via redorbit.com
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