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Dapagliflozin Faces Ominous Prospect Of New Trials

 
• By Emily Hayes

FDA’s rejection of Bristol-Myers Squibb and AstraZeneca’s diabetes drug dapagliflozin may mean new trials are needed, which would be a blow for the drug as well as a bad sign for the new class of SGLT2 inhibitors.

Announcing a “complete response” letter from FDA on its first-in-class type 2 diabetes drug dapagliflozin, which has drawn scrutiny over a suspected link to cancer among other potential safety risks, Bristol-Myers Squibb Co.has notified investors that the agency may be looking for “evidence of additional benefit from ongoing or new studies.”

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