Second complete response letter to Alkermes, Amylin, and Lilly this year requires tQT studies.

Alkermes, Amylin Pharmaceuticals, and Eli Lilly received a second complete response letter regarding the NDA for Bydureon™ (exenatide extended-release for injectable suspension) to treat type 2 diabetes. The agency has now requested a thorough QT (tQT) study with exposures of exenatide higher than typical therapeutic levels of Bydureon. The companies will need to get the tQT protocol okayed by the FDA prior to study initiation.

Additionally, the agency has asked for results of the Duration-5 study to evaluate the efficacy and thus safety and effectiveness labeling details for the commercial formulation of Bydureon.

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 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,” remarks Orville G. Kolterman, M.D., senior vp, CMO, Amylin.

Bydureon is a once-weekly formulation of exenatide, the active ingredient in Byetta®, has been available in the U.S. since June 2005 to improve glycemic control in adults with type 2 diabetes. Both drugs belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.

The NDA for Bydureon was submitted in May 2009 and is based on data that includes the Duration-1 head-to-head clinical study, safety data from Duration-2, and more than seven years of clinical experience with Byetta. The agency first issued a complete response letter to the companies in March. In May the companies’ response was classified as a Class 2 resubmission with a PDUFA action date of October 22.

The March complete response letter raised issues related to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes. It did not make any further requests regarding observations made in December 2009 by FDA’s preapproval inspection team at a manufacturing facility in Ohio.

Today’s complete response letter did not cite any manufacturing processes, and REMS and product labeling discussions will continue following submission of the additional data.

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