FDA Advisory Committee recommends Forxiga for Type 2 Diabetes in USA-AstraZeneca/BMS

AstraZeneca and Bristol-Myers Squibb Company announced the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13-1 that the benefits of Forxiga (dapagliflozin) use outweigh identified risks and support marketing of dapagliflozin as an adjunct to diet and exercise to improve glycaemic control in adults with Type 2 Diabetes mellitus. The Advisory Committee also voted 10-4 that the data provided sufficient evidence that dapagliflozin, relative to comparators, has an acceptable cardiovascular risk profile.

The FDA is not bound by the Advisory Committee�s recommendation but takes its advice into consideration when reviewing the application for an investigational agent. The Prescription Drug User Fee Act (PDUFA) goal date for dapagliflozin is 11 January 2014.