Amylin Pharmaceuticals, Inc, Eli Lilly and Company and Alkermes, Inc announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for Bydureon (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 labelling 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 labelling 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.

"We are committed to working closely with the FDA to resolve the issues raised in the complete response letter so that Bydureon can be approved, and we can make this important treatment available to patients with type 2 diabetes as quickly as possible," said Orville G Kolterman, senior vice president, chief medical officer, Amylin Pharmaceuticals. "We remain confident in Bydureon based on the extensive exenatide database, including more than seven years of clinical experience with Byetta, the twice-daily form of exenatide that is available in more than 60 countries worldwide."

Bydureon (pronounced by-DUR-ee-on) 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.