U.S.
FDA approves expanded use of Novartis heart drug
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[February 17, 2021]
(Reuters) - The U.S. Food and Drug
Administration has approved the expanded use of Novartis' heart failure
medicine Entresto, the Swiss drugmaker said on Tuesday, boosting the
drug's prospects to around $5 billion sales annually.
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The drug won regulatory support for use among heart failure patients
whose heart muscle contracts normally, but the ventricles do not
relax as they should.
It is already prescribed for patients whose heart muscles do not
contract effectively.
In December, an FDA advisory committee voted in favour of use of
Entresto in treatment of patients with so-called preserved ejection
fraction heart failure.
Novartis has said that expanded approval would mean significantly
more sales.
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"We previously guided $3 billion to $4 billion
on reduced ejection fraction heart failure, and
we are guiding $4 billion to $5 billion on
reduced ejection fraction and preserved ejection
fraction together," Marie-France Tschudin,
Novartis' drugs chief said earlier this month.
(Reporting by Mrinalika Roy in Bengaluru and
John Miller; Editing by Shailesh Kuber)
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