FDA approves dapagliflozin

FDA approved an NDA from Bristol-Myers Squibb Co. (NYSE:BMY) for Farxiga dapagliflozin as an adjunct to diet and exercise to improve glycemic control in Type II diabetics. BMS declined to disclose a price or when the product would be launched. Last month, FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13-1 that the benefit-risk profile of the sodium-glucose cotransporter 2 (SGLT2) inhibitor supported approval (see BioCentury, Dec. 23, 2013).

FDA is requiring six postmarketing studies for Farxiga, including a dedicated CV outcomes trial and a double-blind assessment to evaluate bladder cancer risk in patients enrolled in the outcomes trial. The outcomes trial, DECLARE, is already ongoing, with data expected in 2019. In January 2012, BMS and co-development partner AstraZeneca plc (LSE:AZN; NYSE:AZN) received a complete response letter for dapagliflozin in part due to an imbalance in breast and bladder cancers in the clinical program for the drug. ...