Mavacamten in Obstructive HCM: A US FDA Regulatory Reference From 2022

An FDA reference note on the 2022 US approval of mavacamten for symptomatic NYHA class II–III obstructive hypertrophic cardiomyopathy, including the monitoring and REMS requirements highlighted by the regulator.

By the US Food and Drug AdministrationEditorially reviewed by the Iraq Cardiology Review Panel4 min readUpdated August 20, 2026

This is a regulatory reference, not a new 2026 approval. In April 2022, the US Food and Drug Administration approved mavacamten (Camzyos) for adults with symptomatic New York Heart Association class II–III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms.

The FDA summarised a 30-week randomised placebo-controlled study in which 37% of mavacamten-treated participants and 17% of placebo-treated participants met the referenced endpoint combining exercise capacity and symptoms. The regulator also highlighted a central safety issue: reducing contractility can precipitate impaired ventricular function or heart failure.

In the United States, the product is subject to a Risk Evaluation and Mitigation Strategy programme, with echocardiographic monitoring and careful review of interacting medicines. This US regulatory status does not establish local registration, availability, reimbursement, or monitoring pathways in Iraq. Use should always follow the applicable national authority, product label, specialised HCM assessment, and local safety infrastructure.

Editorial note: consult the FDA announcement and prescribing information for the complete US safety and regulatory details.