Bristol Myers Unveils More Mavacamten Data To Backup Case For Heart Drug

Bristol Myers Squibb Co BMY announced a new analysis of data from the Phase 3 EXPLORER-HCM study evaluating mavacamten in patients with obstructive hypertrophic cardiomyopathy (oHCM).
New data were presented at the American College of Cardiology Annual Scientific Session, with simultaneous publication in The Lancet.
After 30 weeks, mavacamten beat placebo at improving patients’ scores from baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ), a measure of how patients perceive their health status, including their heart failure symptoms and how they affect their quality of life and physical and social function.
The analysis also found that more than twice as many patients on mavacamten than placebo (36% versus 15%) logged an improvement of more than 20 points on the questionnaire, where a five-point increase was considered clinically significant.
In March, the FDA picked up Bristol Myers’ application for the drug, setting a review date of January 28, 2022. The agency will review pivotal data from the EXPLORER study showing mavacamten significantly topped placebo in terms of symptoms and cardiac function.
Bristol Myers made a big bet on mavacamten when it agreed to acquire MyoKardia back in October.
Price Action: BMY shares are down 0.28% at $64.70 in the premarket session on the last check Monday.