The FDA has issued a complete response letter regarding the new drug application for Bristol-Myers Squibb (BMS) and AstraZeneca's 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 dapagliflozin."
The FDA also is requesting clinical trial data from ongoing studies and may require information from new clinical trials. New York City-BMS and London-based AstraZeneca said they will 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 countries as part of the application procedures.
BMS and AstraZeneca added that they remain committed to dapagliflozin and its development. "This commitment is based on the benefit-risk profile of this investigational medicine, from a clinical development program 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," the companies wrote in a statement.
Dapagliflozin, an inhibitor of SGLT2, a target in the kidney, is under joint development by BMS and AstraZeneca. Dapagliflozin, as an adjunct to diet and exercise, 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. SGLT2 is a sodium-glucose cotransporter in the kidney and is an insulin-independent pathway for the reabsorption of glucose back into the blood.
BMS and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialize select investigational drugs for type 2 diabetes.