Aficamten: First Approval
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
Abstract:
Aficamten (MYQORZO™) is a small-molecule cardiac myosin inhibitor being developed by Cytokinetics for the treatment of hypertrophic cardiomyopathy (HCM). Supported by the findings of the phase III, randomised, double-blind, placebo-controlled SEQUOIA-HCM trial, in December 2025 aficamten was approved in both China and the USA to improve functional capacity and symptoms in adults with symptomatic obstructive HCM (oHCM). Subsequently, in February 2026, aficamten was also approved in the EU for the treatment of symptomatic oHCM in adult patients. Aficamten is also in phase III evaluation for use in the treatment of non-obstructive HCM (nHCM) in adults. This article summarises the milestones in the development of aficamten leading to this first approval for symptomatic oHCM.
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