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 designed to improve functional capacity and symptoms in patients with oHCM. The approval is based on the results of the SEQUOIA-HCM Phase 3 clinical trial, which demonstrated significant improvements in exercise capacity and symptom reduction. The drug is expected to be available in the U.S. by the second half of January 2026. MYQORZO will be distributed under a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of heart failure associated with its use.
Why It's Important?
The approval of MYQORZO marks a significant advancement in the treatment options available for patients with obstructive hypertrophic cardiomyopathy, a condition that affects the heart muscle and can lead to severe symptoms and reduced quality of life. This development is particularly important as it provides a new therapeutic option for a condition that has limited treatment choices. The approval also highlights Cytokinetics' commitment to advancing muscle biology and developing innovative treatments for cardiovascular diseases. The introduction of MYQORZO could potentially improve the lives of many patients by offering a more effective management of their symptoms and enhancing their overall functional capacity.
What's Next?
Cytokinetics plans to support patients prescribed MYQORZO through a personalized program called MYQORZO & You, which will assist with treatment navigation, education, and financial assistance. The company will also host an investor conference call to discuss the FDA approval and its implications. As MYQORZO becomes available, healthcare providers will need to monitor patients closely due to the associated risks of heart failure, ensuring that the benefits of the treatment outweigh the potential risks. The company will continue to engage with healthcare professionals and patients to optimize the use of MYQORZO in clinical practice.
