FDA accepts approval application from Eli Lilly, Amylin for new diabetes drug

NEW YORK Headline clarification: On Aug. 19, a headline on DrugStoreNews.com incorrectly identified Amgen as part of a partnership with Eli Lilly in the development of a new diabetes drug. Amylin is actually Eli Lilly’s partner on the new drug, a long-acting version of exenatide for Type 2 diabetes.

The Food and Drug Administration has accepted an approval application for a once-weekly formulation of an injectable diabetes drug, according to published reports.

The FDA will consider approval of a long-acting version of exenatide as a treatment for Type 2 diabetes. The drug is made by Indianapolis-based Eli Lilly & Co., San Diego-based Amylin Pharmaceuticals and Cambridge, Mass.-based Alkermes, according to Renal and Urology News. Exenatide is the same active ingredient in the drug Byetta, already approved as a treatment for Type 2 diabetes.

Results of a phase 3 trial announced last month indicated that once-weekly exenatide provided better glucose control than Sanofi-Aventis’ Lantus (insulin glargine [rDNA origin]).