FDA has informed Bristol Myers Squibb (NSDQ:GILD) that it has extended its review of mavacamten, an allosteric modulator of cardiac myosin.
Bristol Myers Squibb aims to win an FDA nod for the drug as a treatment for obstructive symptomatic hypertrophic cardiomyopathy (oHCM), a disease associated with heart muscle thickening.
Mavacamten addresses the molecular defect involved in oHCM.
FDA now expects to decide on whether to approve the drug for oHCM by April 28, 2022.
The agency requested extra time to review Bristol Myers Squibb’s proposed risk evaluation mitigation strategy.
“We are confident in the profile of mavacamten. This first-in-class cardiac myosin inhibitor demonstrated clinically meaningful improvements in symptoms, functional status, and quality of life in symptomatic oHCM patients in the pivotal EXPLORER-HCM trial,” said Dr. Samit Hirawat, EVP, chief medical officer, global drug development at Bristol Myers Squibb, in a statement. “We look forward to continuing to work closely with the FDA to bring this important medicine to patients.”
FDA had initially assigned a target action date of January 28, 2022, to the drug.
In its submission for the drug, BMS submitted data on the Phase 3 EXPLORER-HCM study, which tested mavacamten in participants with symptomatic oHCM against those who received placebo.
The drug candidate was featured in The Lancet in May.
Filed Under: Cardiovascular, Drug Discovery