US FDA approves Bristol Myers’ oral heart disease drug
The company said the drug comes with a boxed warning for the risk of heart failure
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 characterised 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 US 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.
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.
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