FDA declines to approve Bydureon

INDIANAPOLIS The Food and Drug Administration declined to approve a long-anticipated diabetes drug made by Eli Lilly and two other companies, the companies said Tuesday.

Lilly, Amylin Pharmaceuticals and Alkermes said the FDA issued them a complete response letter for their application for Bydureon (exenatide), a once-weekly version of the Type 2 diabetes drug Byetta. A complete response letter means that the FDA has completed review of a regulatory application, but issues remain that preclude approval.

Specifically, the FDA requested a study showing the effects of higher-than-usual exposures to the drug on patients’ heart rates. The agency also asked for additional data on the safety and effectiveness of Bydureon.

The three companies said they hope to file for approval again by the end of next year. They said the resubmission likely will require a six-month review.

Byetta faces competition from Novo Nordisk’s Victoza (liraglutide), as both drugs are injected daily and belong to the same drug class, known as GLP-1 analogues, which work by stimulating  production of the hormone glucagon-like peptide-1. Had it won approval, Bydureon would have given Lilly and the others an advantage due to its more convenient dosing schedule, but the FDA’s complete response letter means Victoza will have a longer period of time in which to take a share of the market from Byetta.