US FDA sets PDUFA action dates for Bydureon and peginesatide

US drugmakers Amylin Pharmaceuticals (Nasdaq: AMLN), Eli Lilly (NYSE: LLY) and Alkermes (Nasdaq: ALKS) said yesterday that the US Food and Drug Administration has acknowledged their resubmission of the New Drug Application for the type 2 diabetes drug candidate Bydureon (exenatide extended-release for injectable suspension), and has assigned a new Prescription Drug User Fee Act (PDUFA) action date of January 28, 2012.

Bydureon, the long-acting formulation of already-marketed Byetta, was recently approved in the European Union (The Pharma Letter June 22) but has so far been delayed in the USA with two complete response letters issued by the FDA in March and October last year, which called for additional clinical data. The companies’ goal had been to re-file the NDA with the required data by end-2011, so the latest move means they have beaten their targets have submitted this last month.

"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 USA," said Christian Weyer, senior vice president, R&D at Amylin, adding:. "We will continue to work with the FDA through this stage of the review process."