U.S. FDA Approves Bristol Myers Squibb's Camzyos™ (mavacamten) for the Treatment of Adults With obstructive HCM

Bristol Myers Squibb BMY announced the U.S. Food and Drug Administration (FDA) approval of  Camzyos™ (mavacamten) for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms. 

Camzyos is the first and only FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of obstructive HCM.

This approval is based on Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos.

Samit Hirawat, M.D., chief medical officer from Global Drug Development, said, “This approval builds on decades of cardiovascular leadership and reflects our steadfast commitment to people impacted by cardiovascular disease. We are proud to bring this first-of-its kind medicine to patients, which may help to address an unmet need in the U.S. in the symptomatic NYHA class II-III obstructive HCM treatment landscape.”

Bristol Myers Squibb traded up 2 percent reaching $77.19 at the market close.