SAN DIEGO — The Food and Drug Administration has acknowledged the resubmission of an investigational Type 2 diabetes drug made by Amylin Pharmaceuticals, Eli Lilly and Alkermes.
The FDA has set a Jan. 28, 2012 deadline for its review of Bydureon (exenatide extended-release for injectable suspension). The drug, which first was submitted to the FDA in May 2009, was declined by the regulatory agency on two occasions; the drug makers received complete response letters in March 2010 and October 2010. Bydureon, however, received marketing authorization in the European Union in June.
"If approved, we believe Bydureon will be an important new option for type 2 diabetes patients, as the first once-weekly treatment available in the U.S.," Amylin SVP research and development Christian Weyer said. "We will continue to work with the FDA through this stage of the review process."