- Cytokinetics has received Health Canada authorization for Myqorzo (aficamten) to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults with NYHA Class II–III disease. The once-daily oral therapy reversibly inhibits cardiac myosin.
- The authorization is supported by the Phase III SEQUOIA-HCM trial, which demonstrated significant improvements in exercise capacity, symptoms, cardiac hemodynamics and biomarkers over 24 weeks.
- Patients receiving Myqorzo improved peak oxygen uptake by 1.76 mL/kg/min from baseline, compared with no change in the placebo group. Treatment-emergent serious adverse events occurred in 5.6% of patients versus 9.3% with placebo.
- Myqorzo carries a boxed warning for heart failure due to reduced left ventricular ejection fraction (LVEF), requiring echocardiographic monitoring before and during treatment. The Canadian authorization follows approvals in the US, China, the EU and UK.
Takeaways:
Health Canada’s authorization expands Cytokinetics’ commercial reach for Myqorzo in oHCM, positioning it against Bristol Myers Squibb’s Camzyos through another once-daily cardiac myosin inhibitor option. Improved exercise capacity and symptoms support its clinical value, while LVEF monitoring requirements, safety management and real-world outcomes will influence physician adoption and market share.
Source: Globenewswire
