|
 The approval by the U.S. Food and Drug Administration is based on
results from the DECLARE-TIMI 58 clinical trial, the London-listed
company said, and follows a similar approval https://www.astrazeneca.com/media-centre/press-releases/2019/forxiga-label-updated-in-the-eu-in-type-2-diabetes.html
by the European authorities in August.
Farxiga is the first of its class to be approved in the United
States for this indication, Ruud Dobber, executive vice president of
BioPharmaceuticals at AstraZeneca said.
"This is promising news for the 30 million people living with type-2
diabetes in the United States, as heart failure is one of the
earliest cardiovascular complications for them, before heart attack
or stroke," Dobber said.
Farxiga, already approved as a treatment for type-2 diabetes, is
part of the SGLT2-inhibitor class of antidiabetics that cause the
kidneys to expel blood sugar from the body through urine.
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Diabetes is often associated with a high risk of heart failure, a
condition in which the blood-pumping organ does not circulate blood
as well as it should.
The treatment, one of AstraZeneca's top 10 drugs by sales, had shown
promise in reducing the risk of heart attacks or disease progression
in patients with the HFrEF subtype of heart failure, accounting for
about half of heart failure cases.
The FDA has already placed Farxiga under speedy reviews to treat
some kinds of heart failure and kidney failure.
(Reporting by Pushkala Aripaka in Bengaluru; Editing by Arun Koyyur)
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