FDA Advisors Recommend Approval of Dapagliflozin for Type 2 Diabetes
Agency decision expected in January 2014 (December 12)
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted 13 to 1 that the benefits of dapagliflozin outweigh identified risks. The committee supported the marketing of the drug as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The committee also voted 10 to 4 that the data provided sufficient evidence that dapagliflozin has an acceptable cardiovascular risk profile compared with that of comparators.
The FDA is not bound by the 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 January 11, 2014.
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. The drug is a selective and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2) that works independently of insulin to help remove excess glucose from the body.
Source: Bristol-Myers Squibb; December 12, 2013.