23 December 2024 - Cytokinetics today announced that the EMA has validated the marketing authorisation application for aficamten, a next in class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy.
The marketing authorisation application is supported by the results from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy, which were published in the New England Journal of Medicine.