Myqorzo (aficamten) launched in European Union, with first commercial availability in Germany – Cytokinetics
Cytokinetics, Incorporated announced the first commercial European launch of Myqorzo (aficamten) in Germany for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients. Myqorzo is an allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition reduces cardiac contractility and consequently, left ventricular outflow tract (LVOT) obstruction.
Marking the first of several planned European launches, the availability of Myqorzo in Germany follows the European Commission approval in February 2026. The approval was based on positive results from SEQUOIA-HCM, the pivotal Phase III clinical trial of aficamten in patients with oHCM, demonstrating robust efficacy, safety, and clinically meaningful benefits across symptoms, exercise capacity, hemodynamics, and biomarker endpoints. These clinical results were published in the New England Journal of Medicine.
“Bringing Myqorzo to Europe marks an exciting new chapter for Cytokinetics as we extend our reach to more patients with symptomatic oHCM,” said Joseph Dagher, Senior Vice President and Head of Europe, Cytokinetics. “This milestone further strengthens our leadership in muscle biology and reinforces Cytokinetics’ commitment to the global HCM community.”
Myqorzo was previously approved in December 2025 by the FDA for the treatment of adults with symptomatic oHCM to improve functional capacity and symptoms, and by the China National Medical Products Administration (NMPA) for the treatment of adults with NYHA class II-III oHCM, to improve exercise capacity and symptoms.
“The latest advancement in myosin inhibition brings a new treatment option into our clinical practice in Europe and Germany to help patients with symptomatic oHCM,” said Prof. Benjamin Meder, FESC, Chair of Precision Digital Health, Head of the Institute for Cardiomyopathies Heidelberg and Deputy Medical Director, Department of Cardiology, Angiology and Pneumology, University Hospital Heidelberg.
The results from SEQUOIA-HCM showed that treatment with aficamten for 24 weeks significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) by 1.76 mL/kg/min compared to baseline in patients treated with Myqorzo versus 0.0 mL/kg/min in patients treated with placebo (least square mean (LSM) difference [95% CI] of 1.74 mL/kg/min [1.04 – 2.44]; p=0.000002). The treatment effect of Myqorzo was consistent across all prespecified subgroups, including age, sex, patient baseline characteristics, and in patients receiving or not receiving background beta-blocker therapy.
Statistically significant (p<0.0001) and clinically meaningful improvements were also observed in all 10 prespecified secondary endpoints, including Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) at weeks 12 and 24, the proportion of patients with ≥1 class improvement in New York Heart Association (NYHA) functional class at weeks 12 and 24, change in provoked left ventricular outflow tract gradient (LVOT-G) and proportion <30 mmHg at weeks 12 and 24, as well as exercise workload and guideline-eligibility for septal reduction therapy.
“Obstructive HCM can have life-altering effects on all aspects of patients’ lives and having more treatments options allows for more personalized choices based on their symptoms and lifestyle,” said Emil Tsenov, Founding and Managing Director, HCM Patient Foundation. “The availability of Myqorzo in Germany brings hope for patients around the European Union and reflects meaningful progress for the HCM community.”
Citation: Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy. Authors: Martin S. Maron, M.D., Ahmad Masri, M.D., Michael E. Nassif, M.D. et al. Published May 13, 2024 N Engl J Med 2024; 390:1849-1861 DOI: 10.1056/NEJMoa2401424 VOL. 390 NO. 20
