U.S. FDA approves expanded use of Novartis heart drug


Аvera Allen, Deputy Editor In Chief

Date: 22.02.2021

The U.S. Food and Drug Administration has approved the expanded use of Novartis’ heart failure medicine Entresto, the Swiss drugmaker, boosting the drug’s prospects to around $5 billion sales annually.

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.

“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.



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