Biotech Values

[DewDiligence]

FDA Extends Review Period for Byetta Monotherapy

http://www.reuters.com/article/marketsNews/idINN0850073820081208

›Mon Dec 8, 2008 8:50am EST

NEW YORK, Dec 8 (Reuters) - U.S. regulators will likely extend their review of Amylin Pharmaceuticals and Eli Lilly's diabetes drug Byetta for use as stand-alone therapy into next year, the companies said on Monday.

The Food and Drug Administration did not request any additional studies, the companies said. The agency is reviewing several Byetta prescribing information updates submitted by the companies, including revision of safety language. [This sounds like a lame reason for a delay. A more honest answer would be that, due to understaffing or other problems, the reviewers didn’t do any reviewing when they were supposed to.]

Amylin shares have been hammered this year largely over safety concerns with Byetta, namely reports of pancreatitis.

Byetta, an injectable drug approved for use by Type 2 diabetics who struggle to control their blood sugar levels, is currently an add-on therapy for patients using older drugs.

The companies submitted their application for use of Byetta as a monotherapy in the first quarter. They said on Monday that it is likely the FDA's review of the application will not be complete by the end of 2008, and may extend into 2009.

"Our discussions with the FDA continue to progress and we remain confident in the strength of our regulatory submission," Orville Kolterman, Amylin's senior vice president of research and development, said in a statement.

Amylin and Lilly are also developing a long-acting version of Byetta known as exenatide LAR, whose fate has come under question in part because of Byetta's safety concerns.‹