AstraZeneca and Bristol-Myers Squibb's experimental diabetes drug dapagliflozin comes with some risks attached, according to FDA staffers. The drug appears to be linked with breast and bladder cancer, and to some serious liver risk. Dapagliflozin is part of a new class of drugs called SGLT2-inhibitors that prevents sugar from being absorbed, forcing it to be excreted through the urine.
"Several unexpected safety issues identified in this clinical development program were of sufficient concern to FDA to merit discussion of their impact on the overall benefit-risk consideration of dapagliflozin," said agency reviewers, according to Bloomberg. Nine cases of bladder cancer and nine cases of breast cancer were found in trial subjects taking the diabetes drug; just one of each type of cancer was found in the control group. Additionally, staffers found that the diabetes treatment may have led to two instances of serious liver injury.
"At the least, we expect a strong warning in the label for the possibility of liver injury, and we also think there could be a requirement for liver function monitoring," ISI Group analyst Mark Schoenebaum told Reuters. "This could reduce the competitiveness of (the drug) in the real world."
While some analysts think an outside panel of experts will still recommend the drug's approval, the agency would likely call for a strong warning about the drug's risks. That may cause physicians to use caution until long-term safety data is available--and could cut into AZ and BMS's bottom line. The FDA's dapagliflozin decision will be closely watched by Johnson & Johnson, Eli Lilly, Boehringer Ingelheim and Astellas Pharma--all of whom are developing their own SGLT2-inhibitors