New Diabetes Drug Approved by FDA
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 cance, 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.
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