FDA approves Bristol Myers’ oral heart disease drug

(Reuters) – Bristol Myers Squibb (BMY.N) said on Thursday the U.S. Food and Drug Administration (FDA) approved its oral heart disease drug Mavacamten, making it the first cardiac myosin inhibitor to be permitted for use in the country.

Mavacamten, which Bristol Myers acquired in its $13 billion buyout of MyoKardia in 2020, will be used in the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy.

Hypertrophic cardiomyopathy is an inherited condition characterized by thickening of heart muscles, which is a common cause of sudden cardiac arrest in young people.

About one in every 500 people in the United States suffers from hypertrophic cardiomyopathy, according to the American Heart Association, with a large portion having obstructive hypertrophic cardiomyopathy.

The wholesale acquisition cost (WAC) per capsule price of Mavacamten is about $245.20. The monthly list price is $7,356.16, while the annual one is $89,500, Bristol Myers told Reuters in an emailed statement.

A woman holds test tube in front of displayed Bristol Myers Squibb logo in this illustration taken, May 21, 2021. REUTERS/Dado Ruvic/Illustration

The company said the drug comes with a boxed warning for the risk of heart failure. Mavacamten reduces left ventricular ejection fraction and can cause heart failure due to systolic dysfunction.

A boxed warning on the label is FDA’s strictest warning and calls attention to serious or life-threatening risks of a drug.

Reporting by Bhanvi Satija, Amruta Khandekar, Jaiveer Singh Shekhawat in Bengaluru and Michael Erman in New Jersey ; Editing by Subhranshu Sahu and Sherry Jacob-Phillips

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