FDAnews Drug Daily Bulletin

Diabetes Drug Byetta Gets FDA Approval

May 12, 2005

The FDA has approved Byetta, a first-in-class Type 2 diabetes injectable drug marketed by Amylin Pharmaceuticals and Eli Lilly.

The firms plan a June 1 launch of Byetta (exenatide) injection, which was approved as an adjunctive therapy to improve blood-sugar control in patients who have not achieved adequate control on two common oral Type 2 diabetes drugs: metformin and/or a sulfonylurea.

The FDA said that Byetta is approvable as a stand-alone therapy. Any additional data submitted to support this indication is expected to receive a six-month review, the firms said.

The product is packaged for self-administration using a pen-injector device and is available in 5- and 10-mcg doses. Amylin and Lilly are positioning Byetta for the more than 6 million Type 2 patients on metformin and/or sulfonylureas, not simply the 1.3 million patients who are failing oral therapy, said a pharmaceutical analyst.