Nov 11, 2021: “Bristol Myers Squibb announced that the U.S. Food and Drug Administration has extended the review of the NDA for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to April 28, 2022.
The FDA notified Bristol Myers Squibb on November 18, 2021 of the extension of the PDUFA date to allow sufficient time to review information pertaining to updates to the proposed Risk Evaluation Mitigation Strategy (REMS).
A REMS program was included in the initial application for mavacamten. No additional data or studies have been requested.
“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 Samit Hirawat, M.D., executive vice president, chief medical officer, global drug development, Bristol Myers Squibb.”
“We look forward to continuing to work closely with the FDA to bring this important medicine to patients.”