US FDA advisory gives thumbs down to B-MS and AstraZeneca diabetes drug dapagliflozin on safety issues

The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee yesterday voted to not recommend approval of Anglo-Swedish drug major AstraZeneca (LSE: AN) and US partner Bristol-Myers Squibb’s (NYSE: BMY) New Drug Application for their investigational type 2 diabetes drug dapagliflozin.

The vote was not a big surprise given that, ahead of the panel meeting, the FDA issued briefing papers highlighting the increased risk of bladder and breast cancer associated with the compound (The Pharma Letter July 18).

On the question: “Do the efficacy and safety data provide substantial evidence to support approval of dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus?” the Advisory Committee voted nine against and six for approval. Panel members said the clinical data did not provide enough certainty about the drug's cancer, liver and kidney risks, as well as its effectiveness - especially for the elderly. However, they also expressed hope that the drug might ultimately be approved if the safety questions are resolved.