What's Happening?
Cytokinetics has announced that the U.S. Food and Drug Administration (FDA) has approved MYQORZO (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). MYQORZO is a cardiac myosin inhibitor that reduces
cardiac contractility and left ventricular outflow tract obstruction, improving functional capacity and symptoms in patients. The approval is based on positive results from the SEQUOIA-HCM Phase 3 clinical trial, which demonstrated significant improvements in exercise capacity and symptom reduction. MYQORZO is the first FDA-approved medicine from Cytokinetics, marking a significant milestone for the company.
Why It's Important?
The approval of MYQORZO provides a new treatment option for patients with obstructive hypertrophic cardiomyopathy, a condition characterized by thickened heart muscle that can obstruct blood flow and lead to severe symptoms. This approval addresses a significant unmet need, as current treatment options are limited. MYQORZO's approval is expected to improve the quality of life for patients by enhancing their exercise capacity and reducing symptoms. The drug's availability through a Risk Evaluation and Mitigation Strategy (REMS) program ensures careful monitoring to manage potential risks, such as heart failure due to systolic dysfunction.
What's Next?
MYQORZO is expected to be available in the U.S. by the second half of January 2026. Cytokinetics will support patients through the MYQORZO & You program, offering assistance with treatment navigation, education, and financial support. The company will also host an investor conference call to discuss the FDA approval and future plans. As MYQORZO becomes available, healthcare providers will need to enroll in the REMS program to prescribe the medication, ensuring patient safety through ongoing monitoring.
