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FDA advises against BMS/AZ diabetes drug

An advisory committee to the US Food and Drug Administration has recommended against the marketing approval for dapagliflozin, a diabetes drug developed by AstraZeneca and Bristol-Myers Squibb

An advisory committee to the US Food and Drug Administration  (FDA) has recommended against the marketing approval for dapagliflozin, a diabetes drug developed by AstraZeneca (AZ) and Bristol-Myers Squibb (BMS).

The Endocrinologic and Metabolic Drugs Advisory Committee  voted nine to six in opposition to a question regarding whether evidence about the drug's safety and efficacy supported its use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Both companies said they remained committed to the development of dapagliflozin, and will work with the FDA in its review of the drug.

The FDA does not have to follow the Committee's recommendation, but it frequently does so, and will take the advice into consideration when reviewing the marketing application.

Dapagliflozin is potentially the first in a new class of insulin-independent, oral type 2 diabetes agent. It is developed as an inhibitor of SGLT2, a 'glucose cotransporter' in the kidney that plays a role in the reabsorption of glucose into the blood.

20th July 2011

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