GlobeNewswire·Jul 30, 2026, 6:20 AM ET

Cytokinetics Announces MHRA Marketing Authorisation for MYQORZO®▼ (aficamten) and Positive Guidance from NICE for Symptomatic Obstructive Hypertrophic Cardiomyopathy in England and Wales

Cytokinetics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation for MYQORZO® (aficamten) to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in eligible adults.
The National Institute for Health and Care Excellence (NICE) issued guidance recommending aficamten for use in eligible adult patients with NYHA class II-III oHCM in England and Wales.
Aficamten is indicated as an add-on to optimised standard care including beta-blockers, non-dihydropyridine calcium-channel blockers, or disopyramide, or as monotherapy if these treatments are contraindicated.
The MHRA approval was based on SEQUOIA-HCM phase 3 data showing a statistically significant improvement in peak oxygen uptake (pVO2) compared with placebo at week 24.
Common adverse reactions reported with aficamten included hypertension (7.7%), palpitations (7.0%), dizziness (4.2%), and systolic dysfunction (3.5%).
MYQORZO is subject to additional monitoring via the MHRA Yellow Card Scheme to identify new safety information quickly.
The drug acts as a cardiac myosin inhibitor to reduce left ventricular outflow tract obstruction by decreasing cardiac contractility.
Cytokinetics expects NHS availability for eligible patients later in 2026 following the regulatory approvals.