New Diabetes Drug Approved by FDA
Jan. 9, 2014 -- A new pill to treat adults with type 2 diabetes has been approved by the U.S. Food and Drug Administration.
Farxiga (dapaglifozin) tablets were approved to improve patients' blood sugar control, in combination with diet and exercise. The approval is based on findings from 16 clinical trials that included more than 9,400 people with type 2 diabetes.
An increased number of bladder cancers were diagnosed among patients who took the drug, so it is not recommended for patients with bladder cancer, the FDA said. The most common side effects among patients who took Farxiga were genital fungal infections and urinary tract infections.
The FDA ordered six post-approval studies for the drug. The studies will examine things such as cardiovascular and bladder cancer risk, liver problems, and pregnancy outcomes among patients taking the drug. Two studies will assess the use of the drug in children.
Farxiga is marketed by Bristol-Meyers Squibb Company and AstraZeneca Pharmaceuticals.