FDA committee rejects dapagliflozin

20th Jul 2011 07:03

Drugs giants AstraZeneca and Bristol-Myers Squibb received a blow when the US Food and Drug Administration's (FDA) Advisory Committee rejected their jointly-developed diabetes drug, dapagliflozin, though the vote was a close one.The committee voted 6 "yes" and 9 "no" on the question of whether "do the efficacy and safety data provide substantial evidence to support approval of dapagliflozin as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus?". "While I really liked the concept, we just don't have enough right now, in my opinion, to ensure safety and efficacy and how to use it," Dr. David Capuzzi, a member of the committee who voted no was reported as saying by the New York Times.Bristol-Myers Squibb and AstraZeneca said they remain committed to the dapagliflozin clinical development programme and will continue to work closely with the FDA to support the review of this investigational compound.The FDA is not bound by the Advisory Committee's recommendation but takes its advice into consideration when reviewing new drug applications. The Prescription Drug User Fee Act (PDUFA) goal date for dapagliflozin is 28 October 2011. --jh