Bristol-Myers Squibb Co. (BMY: Quote) and AstraZeneca PLC (AZN, AZN.L) said late Tuesday that the U.S. Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee has voted 9-6 against recommending approval of dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Dapagliflozin is being jointly developped by Bristol-Myers Squibb and AstraZeneca. Dapagliflozin, an inhibitor of SGLT2, a target in the kidney, would potentially be the first in a new class of insulin-independent, oral type 2 diabetes agents.
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 goal date for dapagliflozin is October 28.
Bristol-Myers Squibb and AstraZeneca said they remain committed to the dapagliflozin clinical development program and that they will continue to work closely with the FDA to support the review of the investigational compound.
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by RTT Staff Writer
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