Cytokinetics announces EMA validation of marketing authorisation application for aficamten for the treatment of obstructive hypertrophic cardiomyopathy

Cytokinetics

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.

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Michael Wonder

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Michael Wonder

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Medicine , Europe , Dossier