FDA declined approval of the diabetes drug dapagliflozin (Bristol-Myers Squibb and AstraZeneca), based on the recommendations of one of its advisory committees.
FDA declined approval of the diabetes drug dapagliflozin (Bristol-Myers Squibb and AstraZeneca), based on the recommendations of 1 of its advisory committees.
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 9 to 6 that the investigational drug should not be approved to treat type 2 diabetes.
Dapagliflozin is an inhibitor of SGLt2, a target in the kidney. The drug is under joint development by Bristol-Myers Squibb and AstraZeneca.
The committee said that more data is needed because of safety concerns linking dapagliflozin with breast cancer and bladder cancer. An FDA review of the data found a fourfold increased risk for breast cancer and fivefold increased risk for bladder cancer with dapagliflozin.
FDA is asking the drug’s manufacturers to provide more data about its risk to benefit profile and possibly new clinical trials, but the companies remain optimistic about dapagliflozin’s approval in the future.
“Bristol-Myers Squibb and AstraZeneca remain committed to dapagliflozin and its development. This commitment is based on the benefit to 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 2 drug-makers said in a joint statement.