New York Heart Association (NYHA) Class II-III Hypertrophic Obstructive Cardiomyopathy (see Hypertrophic Cardiomyopathy)
FDA Approved for This Indication in 2022
The approval was based on data from the randomized, multicenter, double-blind, placebo-controlled, parallel-group phase 3 EXPLORER-HCM trial (ClinicalTrials.gov Identifier: NCT03470545), which assessed the efficacy and safety of mavacamten in 251 adults with symptomatic, obstructive HCM. Patients were randomly assigned 1:1 to receive a starting dose of mavacamten 5mg orally once daily or placebo for 30 weeks. The mavacamten dose was periodically adjusted to optimize patient response (decrease in LVOT gradient with Valsalva maneuver) and maintain LVEF of 50% or greater
Contraindicated with the concomitant use of moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers. Concomitant use of Camzyos and drugs that interact with these enzymes may lead to life-threatening drug interactions such as heart failure or loss of effectiveness
U.S. Food and Drug Administration approves Camzyos™ (mavacamten) for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. News release. Bristol Myers Squibb. Accessed April 28, 2022. https://www.businesswire.com/news/home/20220428006368/en
