A new pill to treat diabetes is being scrutinized by a panel of federal regulators to determine if the drug’s benefits outweigh the potential of developing breast and bladder cancer. The advisory panel will weigh data from clinical trials of the Bristol-Myers Squibb/AstraZeneca drug dapagliflozin and make a recommendation to the Food and Drug Administration (FDA) whether to approve it for U.S. consumers.
Diabetes drugs are of particular concern to the FDA since GlaxoSmithKline’s top-selling Avandia was linked to heart attacks beginning in 2007 and ultimately banned from European markets and severely restricted in the United States.
If approved, dapagliflozin would be the first in a new class of drugs called SGLT2-inhibitors that work by allowing excess blood sugar to be excreted in the urine. Similar drugs are also being developed by pharmaceutical companies including Johnson & Johnson and Eli Lilly & Co.
Analysts say, based on the data from clinical trials, the approval for dapagliflozin will be an uphill battle. In trials, there were nine cases of bladder cancer occurring in male patients who took the drug compared to one case among patients who were treated with a placebo. Breast cancer occurred in nine patients who took dapagliflozin, compared to one patient who took the placebo.
As the news broke Monday, Bristol-Myers closed 13 cents down in the New York Stock Exchange composite trading, and AstraZeneca gained 6 pence in London trading.
The FDA panel begins its review of dapagliflozin this week. Bristol-Myers and AstraZenica say they expect to have a final decision on approval by October 28.