FDA reviewers again question dapagliflozin's benefit-risk profile

FDA reviewers said the potential benefits of dapagliflozin from Bristol-Myers Squibb Co. (NYSE:BMY) to treat Type II diabetes must be weighed against "credible safety concerns," including a possible increased risk of bladder cancer and uncertainty about the CV risk. There were 10 cases of bladder cancer in 5,936 (0.17%) patients treated with dapagliflozin vs. one case in 3,403 (0.03%) patients treated with placebo. In its original 2011 NDA, Bristol-Myers reported nine cases of bladder cancer. The pharma received a complete response letter from FDA in January 2012 in which FDA requested additional data to assess the cancer and CV risks of the sodium-glucose cotransporter 2 (SGLT2) inhibitor. ...