Strong FDA advisory panel backing for Bristol-Myers/AstraZeneca’s diabetes drug
The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) yesterday voted 13 to one that the benefits of dapagliflozin use outweigh identified risks and support marketing of the drug as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The expert panel also voted 10-four that the data provided sufficient evidence that dapagliflozin, relative to comparators, has an acceptable cardiovascular risk profile. The drug is under development by US drug major Bristol-Myers Squibb (NYSE: BMY) and partner Anglo-Swedish pharma firm AstraZeneca (LSE: ANZ).
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 Jan. 11, 2014.
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