Novartis Heart Failure Drug Approved by FDA

By Angela Chen 

Novartis AG's Entresto drug has been approved by the U.S. Food and Drug Administration for the treatment of heart failure.

The FDA's decision is based on a study that enrolled nearly 8,5000 patients. The study ended early when it showed that Entresto "significantly" reduced the risk of death when compared with a treatment called enalapril, according to the Swiss pharmaceutical company.

The treatment, also known as sacubitril/valsartan, is usually prescribed alongside other heart failure therapies for patients with reduced ejection fraction, meaning their heart muscle that doesn't contract effectively.

Entresto is undergoing review in several countries and, if approved, could have sales of more than $5 billion, Novartis said.

It added that nearly six million people in the U.S. have heart failure, of which about half have the form with reduced ejection fraction.

Novartis most recently reported a rise in first-quarter earnings, after it closed deals with GlaxoSmithKline and Eli Lilly and Co.

Write to Angela Chen at [e-mail]

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