FDA
FDA greenlights aficamten for symptomatic obstructive hypertrophic cardiomyopathy
Drug: Myqorzo (aficamten)
Indication: Treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms
Pharmacology: Cardiac myosin inhibitor, reduces cardiac contractility
Approval date: December 19, 2025
Availability
Because of the risk of heart failure due to systolic dysfunction, Myqorzo is available only through a Risk Evaluation and Mitigation Strategy (REMS) safety program: MYQORZO REMS Program. Prescribers must be certified by enrolling in the program. Patients must also enroll in the program and comply with ongoing monitoring requirements. Pharmacies must be certified by enrolling in the program and must only dispense to patients who are authorized to receive the drug.
Boxed warnings
- Myqorzo reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.
- Echocardiogram assessments are required prior to and during treatment with Myqorzo to monitor for systolic dysfunction.
- Initiation of Myqorzo in patients with LVEF <55% is not recommended.
- Decrease the dose of Myqorzo if LVEF is <50% and ≥40%. Interrupt the dose of Myqorzo if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction.
- Myqorzo is available only through a restricted program under a REMS called the MYQORZO REMS Program.
Source:
Myqorzo (aficamten) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219083s000lbl.pdf. Accessed January 2, 2026.