The ball is in FDA's court

EMEA's recent approval of Victoza liraglutide for Type II diabetes could ease the path for FDA approval of the once a day GLP-1 analog from Novo Nordisk A/S. Ironically, it also could remove a potential barrier to approval of a rival long-acting GLP-1 analog, exenatide once weekly from Amylin Pharmaceuticals Inc.

Victoza and exenatide once weekly have been shadowing each other through the clinic and the regulatory process. FDA accepted Amylin's NDA for exenatide once weekly the day after Victoza's European approval was announced. The company did not announce the PDUFA date, but it is likely to be in March 2010...