The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application for mavacamten in symptomatic obstructive hypertrophic cardiomyopathy to reduce the need for septal reduction therapy (SRT).

Mavacamten is an oral, selective allosteric inhibitor of cardiac myosin. The submission is supported by data from the phase 3 VALOR-HCM trial (ClinicalTrials.gov Identifier: NCT04349072), which evaluated the effects of mavacamten in 112 patients with symptomatic obstructive hypertrophic cardiomyopathy (NYHA class III-IV) who met the guideline criteria for SRT and had been referred for an invasive procedure. The trial met its primary and secondary endpoints and no new safety signals were observed.

A Prescription Drug User Fee Act (PDUFA) target date of June 16, 2023 has been set for the application.

Mavacamten is currently approved under the brand name Camzyos® for adults with symptomatic NYHA class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms.

Reference

US Food and Drug Administration (FDA) accepts supplemental New Drug Application for Camzyos® (mavacamten) in symptomatic obstructive hypertrophic cardiomyopathy to reduce the need for septal reduction therapy. News release. October 21, 2022. https://www.businesswire.com/news/home/20221020006130/en/U.S.-Food-and-Drug-Administration-FDA-Accepts-Supplemental-New-Drug-Application-for-CAMZYOS%C2%AE-mavacamten-in-Symptomatic-Obstructive-Hypertrophic-Cardiomyopathy-to-Reduce-the-Need-for-Septal-Reduction-Therapy