Dapagliflozin’s Commercial Appeal Could Dim With Bladder Cancer Concerns

23 Dec 2013

Lingering questions surrounding an imbalance in bladder cancer cases – and how FDA decides to handle the issue in labeling – could threaten the diabetes drug’s uptake, particularly given the absence of a similar signal for J&J’s competing SGLT-2 inhibitor Invokana, already on the market.

Though it now has an FDA advisory committee endorsement in its pocket, Bristol-Myers Squibb Co. and AstraZeneca PLC’s Farxiga (dapagliflozin) could face a difficult competitive environment if approved, given lingering concerns about bladder cancer risk and restrictions against use in type 2 diabetics with moderate to severe renal impairment.

The safety-related concerns, coupled with its second-in-class status, could prove a challenge for dapagliflozin as it attempts to cut into...