Amylin seeks FDA approval on Byetta

SAN DIEGO The three companies that developed a twice-daily diabetes drug announced that they had submitted a regulatory application to the Food and Drug Administration for a new formulation of the drug, administered once a week.

Eli Lilly & Co., Amylin Pharmaceuticals and Alkermes said they had submitted the application for a once-weekly formulation of Byetta (exenatide) injection, used to treat Type 2 diabetes.

“The exenatide once-weekly submission is an important milestone in the overall exenatide development program,” Amylin president and CEO Daniel Bradbury. “The clinical data supporting this submission highlight the potential of exenatide once-weekly to significantly advance the treatment of Type 2 diabetes.”