Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for mavacamten, an investigational, first-in-class cardiac myosin inhibitor, for the treatment of patients with obstructive hypertrophic cardiomyopathy (obstructive HCM). Validation of the application confirms the submission is complete, and the EMA’s centralized procedure with Committee for Medicinal Products for Human Use (?CHMP)’s assessment begins. The application is based on the results of the pivotal Phase 3 EXPLORER-HCM trial, which evaluated mavacamten in patients with symptomatic obstructive HCM versus placebo. Results from the trial showed mavacamten demonstrated a clear treatment effect, with clinically meaningful improvements in symptoms, functional status and quality of life, as well as the ability to relieve left ventricular outflow tract obstruction. In the EXPLORER-HCM study all primary and secondary endpoints were met with statistical significance.