Firms say new clinical trials may also be needed.
Bristol-Myers Squibb (BMS) and AstraZeneca received a complete response letter from FDA regarding the NDA for dapagliflozin as a treatment of type 2 diabetes in adults. The agency would like to see additional clinical data to better assess the benefit-risk profile of the drug.
FDA has asked for clinical trial data from ongoing studies and may require information from new clinical trials. Dapagliflozin’s original PDUFA date was back in October 2011. At that time, FDA extended the action date by three months, asking for results from recently completed and ongoing Phase III trials with the drug.
BMS and AstraZeneca note that the clinical development program for dapagliflozin to date has 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 inhibits SGLT2, a target in the kidney. It 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 antidiabetic agents.
The kidney plays an important role in glucose balance, normally filtering about 180 g of glucose each day, with virtually all glucose being reabsorbed back into circulation. SGLT2 is a major sodium-glucose co-transporter in the kidney and is an insulin-independent pathway for the reabsorption of glucose back into the blood.