Overview
- On 11 December 2025, the EMA’s CHMP issued a positive opinion for Myqorzo to treat symptomatic NYHA class II–III oHCM in adults.
- Aficamten is a reversible cardiac myosin inhibitor that lowers contractility by preventing myosin from entering the force‑producing state.
- In a phase 3 randomized, placebo‑controlled trial, aficamten improved exercise capacity and reduced the need for septal reduction therapy versus placebo.
- Reported common side effects include dizziness, systolic dysfunction defined as LVEF below 50%, palpitations and hypertension.
- The product is slated in 5 mg, 10 mg, 15 mg and 20 mg tablets, with initiation by physicians experienced in cardiomyopathy and detailed guidance to follow in the SmPC after a European Commission decision.