Bristol Myers : FDA to Review Mavacamten in Hypertrophic Cardiomyopathy

 Bristol Myers Squibb Co. on Friday said the U.S. Food and Drug Administration accepted its new-drug application for mavacamten for patients with symptomatic obstructive hypertrophic cardiomyopathy.

The New York biopharmaceutical company said the agency set a target action date of Jan. 28, 2022, for the application.

Bristol Myers said mavacamten is a first-in-class myosin inhibitor developed to address the underlying molecular defect of hypertrophic cardiomyopathy, the most common inherited heart disease.

The company said its FDA filing is based on the results of a Phase 3 study in which mavacamten showed a robust treatment effect and met all primary and secondary endpoints.

Mavacamten was the lead product candidate of MyoKardia Inc., which Bristol Myers bought last year for about $13.1 billion.

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