January 27, 2012: Bristol-Myers Squibb and AstraZeneca have received from the FDA a complete response letter to their NDA for investigational compound dapagliflozin for the treatment of type 2 diabetes in adults requesting additional clinical data to allow a better assessment of the benefit-risk profile for the compound. This includes clinical trial data from ongoing studies and may require information from new clinical trials. The companies said they would work closely with the FDA to determine the appropriate next steps for the dapagliflozin application, and are in ongoing discussions with health authorities in Europe and other regions as part of the application procedures.
BMS and AstraZeneca said their commitment to dapagliflozin and its development was based on the benefit-risk profile of the investigational medicine from a clinical development programme that included more than 8,000 adult patients with type 2 diabetes (with more than 5,000 patients treated with dapagliflozin) in 19 clinical trials.
Dapagliflozin, an inhibitor of SGLT2, a target in the kidney, is under joint development by the companies. As an adjunct to diet and exercise, it is being investigated to evaluate its safety and efficacy in improving glycemic control in adults with type 2 diabetes for use as a monotherapy and in combination with other anti-diabetic agents.
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