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FDA advisory committee recommends AstraZeneca PLC And Bristol-Myers Squibb Co investigational SGLT2 inhibitor dapagliflozin


Thursday, 12 Dec 2013 06:59pm EST 

AstraZeneca PLC and Bristol-Myers Squibb Co:Says FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13-1 that the benefits of dapagliflozin use outweigh identified risks and support marketing of dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Says the advisory committee also voted 10-4 that the data provided sufficient evidence that dapagliflozin, relative to comparators, has an acceptable cardiovascular risk profile.Says dapagliflozin is being reviewed by the FDA for use as monotherapy and in combination with other antidiabetic agents, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.Says dapagliflozin is currently approved under the trade name [Forxiga] for the treatment of adults with type 2 diabetes, along with diet and exercise, in 38 countries, including the European Union and Australia. 

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