Bristol Myers Squibb said Thursday that the US Food and Drug Administration (FDA) has approved its oral cardiovascular drug Mavacamten, making it the first cardiac myosin inhibitor approved for use in the country.
Mavacamten, which Bristol Myers acquired in a $13 billion buyout of MyoKardia in 2020, will be used to treat adults with New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy.
Hypertrophic cardiomyopathy is an inherited disease characterized by thickening of the heart muscle, which is a common cause of sudden cardiac arrest in young people.
According to the American Heart Association, approximately one in every 500 people in the United States suffers from hypertrophic cardiomyopathy, with a large proportion suffering from obstructive hypertrophic cardiomyopathy.
The Wholesale Cost of Acquisition (WAC) for a Mavacamten capsule is approximately $245.20. The monthly list price is $7,356.16 and the annual list price is $89,500, Bristol Myers told Reuters in an emailed statement.
The company said the drug comes with a heart failure risk warning. Mavacamten reduces the left ventricular ejection fraction and may cause heart failure due to systolic dysfunction.
The boxed warning on the label is the most severe FDA warning and draws attention to serious or life-threatening risks associated with a drug.