Cytokinetics Reports the US FDA’s NDA Acceptance of Aficamten to Treat Obstructive Hypertrophic Cardiomyopathy
Shots:
- The US FDA has accepted NDA of aficamten (cardiac myosin inhibitor) to treat obstructive hypertrophic cardiomyopathy (HCM) based on P-III (SEQUOIA-HCM) study (PDUFA: Sep 26, 2025)
- P-III (SEQUOIA-HCM) study of aficamten vs PBO showed improved exercise capacity & increased peak oxygen uptake by 1.8ml/kg/min after 24wks. Significant improvements were also seen in all 10 2EPs such as LVOT gradient, NYHA class, KCCQ-CSS, LVOT gradient <30 mmHg, SRT eligibility & CPET workload at 12 & 24wks.
- Additionally, aficamten is being studied in P-III MAPLE-HCM (aficamten vs metoprolol in obstructive HCM), ACACIA-HCM (non-obstructive HCM), CEDAR-HCM (pediatric obstructive HCM) & FOREST-HCM (open-label extension in HCM)
Ref: Cytokinetics | Image: Cytokinetics
Related News: Bayer Join Forces with Cytokinetics to Develop and Commercialize Aficamten in Japan
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
