Overview
- The FDA cleared Myqorzo (aficamten) for adults with symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms in Class II–III patients.
- An allosteric, reversible cardiac myosin inhibitor, Myqorzo reduces contractility and left ventricular outflow tract obstruction and will be available as 5, 10, 15 and 20 mg tablets.
- The prescribing information carries a boxed warning for heart failure and a REMS program, with echocardiograms required and LVEF-based rules that avoid initiation below 55%, prompt dose reduction below 50% to ≥40%, and call for interruption below 40% or with symptomatic systolic dysfunction.
- Cytokinetics expects U.S. supply in the second half of January 2026 and will offer a MYQORZO & You support program for education, access and insurance assistance.
- The approval is Cytokinetics’ first in the U.S. and sets up direct competition with Camzyos, with analysts highlighting more flexible dosing, fewer echocardiograms and minimal drug–drug interaction monitoring; BioPharma Dive also reports a recent clearance in China.