Amylin Pharmaceuticals, Inc, Eli Lilly and Company and Alkermes, Inc announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by the US Food and Drug Administration (FDA).
Exenatide once weekly is an investigational sustained release medication for type-2 diabetes that is injected subcutaneously and administered only once a week. Exenatide is the active ingredient in Byetta (exenatide) injection, which is currently available in the U.S. and in many countries worldwide for people with type-2 diabetes who are unable to achieve good glycemic control with common oral therapies.
"Acceptance of the NDA submission for exenatide once weekly is an important milestone both in the exenatide development program and in the treatment of type 2 diabetes," said Orville G Kolterman, senior vice president of research and development at Amylin Pharmaceuticals. "If approved, this therapy could fill an important unmet need for treating patients with type-2 diabetes with just one dose per week."
Byetta is the first and only FDA-approved incretin mimetic for the treatment of type-2 diabetes. Byetta exhibits many of the same effects as the human incretin hormone glucagon like peptide-1 (GLP-1).