FDA to decide on Bydureon in January 2012

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Amylin Pharmaceuticals, Eli Lilly and Alkermes announced that the FDA acknowledged the companies’ Bydureon resubmission. The FDA categorized it as a Class II resubmission requiring up to six months for review and assigned a new Prescription Drug User Fee Act (PDUFA) action date of Jan. 28, 2012.

In the U.S., Bydureon is currently an investigational medication for type 2 diabetes. Bydureon and Byetta belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.

If approved, Bydureon will be the first once-weekly treatment available in the U.S., said Christian Weyer, MD, senior vice president, research and development of the San Diego-based Amylin. “We will continue to work with the FDA through this stage of the review process,” he said last week.

Bydureon is the proposed brand name for exenatide extended-release for injectable suspension. It is designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. Bydureon is a formulation of exenatide, the active ingredient in Byetta (exenatide) injection, which has been available in the U.S. since June 2005 and is used in more than 70 countries. Bydureon received marketing authorization in the European Union in June.

The new drug application (NDA) for Bydureon was submitted in May 2009. It is based on safety and efficacy data from the DURATION trial program and the Byetta NDA, as well as post-marketing experience with Byetta. The FDA issued complete response letters to the companies in March 2010 and October 2010.