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

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Bristol Myers Unveils More Mavacamten Data To Backup Case For Heart Drug
  • Bristol Myers Squibb Co (NYSE: BMYannounced 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.
 

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Posted-In: Briefs obstructive hypertrophic cardiomyopathyBiotech M&A News Health Care FDA General

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