Exenatide once weekly NDA submitted to FDA

The USA's Amylin Pharmaceuticals has submitted a New Drug Application for exenatide once weekly to the Food and Drug Administration. The  agent, which is also being developed with US drug major Eli Lilly and  Alkermes, is injected subcutaneously once a week.

Exenatide is the active ingredient in Byetta injection, which is  currently available in the USA and in many countries worldwide for  type 2 diabetes, but must be taken twice a day.

Clinical components of the NDA include the DURATION-1 study and the  meta-analysis of primary cardiovascular events across the Byetta  clinical database. DURATION-1 tested exenatide once weekly versus  Byetta.