A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
Latest Information Update: 04 Dec 2024
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At a glance
- Drugs Aficamten (Primary)
- Indications Hypertrophic cardiomyopathy
- Focus Registrational; Therapeutic Use
- Acronyms SEQUOIA-HCM
- Sponsors Cytokinetics
- 02 Dec 2024 According to a Cytokinetics media release, company announced that the U.S. Food & Drug Administration (FDA) has accepted the company New Drug Application (NDA) for aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM), PDUFA Target Action Date Set for September 26, 2025. The results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial, which form the foundation of the NDA.
- 16 Nov 2024 According to a Cytokinetics media release, data from the study were presented at the American Heart Association Scientific Sessions 2024 in Chicago, IL.
- 16 Nov 2024 Results presented in the Cytokinetics Media Release.