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Endocrinologic and Metabolic Drugs Advisory Committee


The committee discussed the cardiovascular risk assessment of drugs for the treatment of type 2 diabetes mellitus and related FDA guidance (“Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes” (2008)).

A narrow majority of the committee, 10 of 19 members, voted that an unacceptable increase in cardiovascular risk should be excluded for all new drugs to improve glycemic control in patients with type 2 diabetes, regardless of the presence or absence of a signal for cardiovascular risk in the development program.

A narrow minority of the committee, 9 of 19 members, voted that an unacceptable increase in cardiovascular risk should not be excluded for all new drugs to improve glycemic control in patients with type 2 diabetes, regardless of the presence or absence of a signal for cardiovascular risk in the development program.