Human medicines European public assessment report (EPAR): Myqorzo, aficamten, Status: Opinion

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Source: EMA New Medicines

Original: https://www.ema.europa.eu/en/medicines/human/EPAR/myqorzo...

Published: Fri, 12 Dec 2025 14:00:00 +0100

Myqorzo (aficamten) is an oral selective cardiac myosin inhibitor developed for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults.1 On 11 December 2025, the CHMP issued a positive opinion recommending marketing authorisation in the EU; a final Commission decision is expected subsequently.[1] The main evidence comes from the randomised, placebo-controlled phase 3 SEQUOIA-HCM trial, in which 24-week treatment with aficamten significantly improved exercise capacity as measured by pVO2 versus placebo (mean increase ~1.8 mL/kg/min vs 0.0 mL/kg/min; LSM difference 1.74 mL/kg/min; p=0.000002).[2][4] In SEQUOIA-HCM, treatment also reduced the need for septal reduction therapy and improved NYHA classification in patients compared to placebo.[1][4] The most commonly reported adverse effects were dizziness, decrease in left ventricular ejection fraction (LVEF <50%), palpitations, and hypertension; LVEF <50% occurred in 3.5% of patients treated with Myqorzo versus 0.7% in the placebo group in one analysis.2][2] Myqorzo decreases cardiac contractility and may cause heart failure; therefore, echocardiographic checks are required prior to and during treatment and initiation at LVEF <55% is not recommended.[2][4] Treatment should be initiated by physicians experienced in the management of cardiomyopathies, and detailed recommendations will be provided in the Summary of Product Characteristics after licensure.[1