European drug regulators have approved the experimental drug Forxiga, known by the generic name dapagliflozin, a once-daily pill for adult type 2 diabetes. It is the first drug approved in a new class of medications called SGLT2 inhibitors. The same drug was rejected in January by the U.S. Food and Drug Administration (FDA) because of concerns that the medication increased the risk of bladder cancer and breast cancer.
Dapagliflozin works by increasing renal glucose elimination, thereby allowing more sugar to be excreted in the urine. During clinical trials nine out of 5,478 patients who were taking the drug were diagnosed with bladder cancer compared to one out of 3,156 patients who were given a placebo. There were also nine cases of breast cancer in the 2,223 women who used the drug compared to one in the 1,053 women in the placebo group.
Dapagliflozin is made by drug makers Bristol-Myers Squibb Co., and AstraZeneca PLC. Its approval by the European Union marks its first major clearance. The drug companies say they plan to provide additional data on the drug from ongoing patient studies and will reapply for approval in the United States in mid-2013.
The FDA has been more cautious with its reviews of new type 2 diabetes drugs in recent years. In 2010, the agency placed severe restrictions on Avandia after it was tied to fatal heart attacks. A year later, the agency issued a warning on Actos, stating that studies showed an increased risk for bladder cancer in patients who used the drug.
Source: USA Today