The FDA has approved dapagliflozin (Farxiga) for treatment of type 2 diabetes in adults, along with diet and exercise, the agency said in a statement.
The approval comes with strings, however: drugmakers Bristol-Myers Squibb and AstraZeneca must conduct six post-market studies, which include a cardiovascular outcomes trial in patients with baseline cardiovascular disease risks, a bladder cancer risk trial, an animal study looking at drug-induced urinary flow and bladder tumor promotion, two trials on risks in pediatric patients, and an enhanced pharmacovigilance program to study liver abnormalities and pregnancy outcomes.