In the U.S., firms are preparing to submit a response to FDA’s previously issued CRLs by the end of this year.
The European Commission cleared Eli Lilly, Amylin Pharmaceuticals, and Alkermes’ long-acting exenatide injection, Bydureon™, for the treatment of type 2 diabetes. Approval covers use of Bydureon in combination with either metformin, a sulfonylurea, a thiazolidinedion, metformin plus a sulfonylurea, or metformin plus a thiazolidinedione.
The firms claim the GLP-1 receptor agonist is the first once-weekly treatment for diabetes approved in Europe. Bydureon is a sustained-release formulation of the approved diabetes drug exenatide (Byetta™), which has been commercially available for over six years. In contrast wtih immediate-release exenatide, Bydureon has been developed using Alkermes’ biodegradable microsphere technology , which enables continuous release with one weekly dose.
Clearance of Bydrureon in the EU was based on data from the Duration clinical program, which demonstrated that the drug resulted in improvements in glycemic control based on reductions in HbA1C levels of 1.5–1.9% after six months. Treatment with the drug also led to weight-loss.
A Bydureon NDA was submitted to FDA for approval in May 2009, but the agency responded with two complete response letters, in March and October 2010. In the first it raised issues related to the finalization of the product labeling with an accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes.
In the second it requested a thorough QT (tQT) study with exposures of exenatide higher than typical therapeutic levels of Bydureon. The firms say they plan to submit a response to the agency during the second half of this year. The companies will in addition have to get tQT protocol cleared by FDA prior to starting the study.