Almost two years after it was put on hold by the FDA, the type 2 diabetes drug dapagliflozin received a vote of confidence from the agency’s advisory panel.
The Endocrinologic and Metabolic Drugs Advisory Committee voted 13-1 that the drug’s benefits outweighed risks and 10-4 that it showed an acceptable cardiovascular risk profile.
In January 2012, the FDA issued a complete response letter to makers Bristol-Myers Squibb and AstraZeneca requesting additional clinical data to its benefit-risk profile. Dapagliflozin (Forxiga) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that works independently of insulin to help remove excess glucose from the body.
The companies said in response to the FDA’s request that they provided additional long-term data as well as data from ongoing studies. Dapagliflozin is being proposed alone and in combination with other drugs as an adjunct to diet and exercise for glycemic control in adults with type 2 diabetes. It has been approved in 38 countries.
Earlier this year, the advisory panel voted in favor of another SGLT2 inhibitor, canagliflozin (Invokana, Janssen Research & Development). The FDA approved canagliflozin a few months later.
The FDA usually, but not always, follows the panel’s recommendations.