Lilly, Amylin Resubmit Bydureon Application - Drug Discovery and Development

INDIANAPOLIS (AP) – Drugmakers Eli Lilly and Co. and Amylin Pharmaceuticals Inc. said they have resubmitted to the Food and Drug Administration their application for a longer-lasting version of the diabetes treatment Byetta, and they expect the review to take up to six months.

The companies received European approval last month for the drug, labeled Bydureon, which is designed to be taken once a week. It is currently available in the United Kingdom.

Byetta, or exenatide, is taken twice a day and has been on the market for several years. Lilly, based in Indianapolis, and Amylin, headquartered in San Diego, are developing Bydureon along with Alkermes Inc. of Waltham, Mass. Alkermes created the technology that gradually releases the drug over the course of a week.

Last fall, the FDA declined to approve Bydureon and asked the companies to run a thorough study that evaluated effects of bigger doses of Bydureon on patient heart rates.

The companies said their reply contained results from the requested study, updated safety information and results from a study comparing Bydureon to Byetta.

In March, the companies said Bydureon proved inferior to Novo Nordisk’s Victoza according to initial results from a late-stage study. They said Bydureon reduced average blood sugar levels in type 2 diabetes patients by a smaller amount from a baseline measurement than Victoza. The study compared Bydureon with a maximum approved dose of 1.8 milligrams of Victoza administered daily.

Date: July 28, 2011
Source: Associated Press