Federal drug regulators have pushed off a decision by three months on dapagliflozin, a diabetes drug that AstraZeneca is co-developing with Bristol-Myers Squibb. That’s according to a company announcement today. A regulatory decision had been expected by Friday.
Both companies said today that regulators at the U.S. Food and Drug Administration have requested more information on the experimental drug. This comes after an FDA staff review in July highlighted concerns that dapagliflozin could increase risks of bladder and breast cancer. In trials, nine patients reported bladder cancer, compared to only one on placebo. The numbers were the same for breast cancer. An advisory panel to the FDA voted 9-6 on July 19, recommending against approval.
Dapagliflozin is a once-daily pill designed to eliminate blood sugar through urine. Analysts surveyed by Bloomberg News expected the drug to generate $144 million for AstraZeneca in 2015.