19 November 2021 - Bristol Myers Squibb today announced that the U.S. FDA has extended the review of the new drug application for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy to 28 April 2022.

The FDA notified Bristol Myers Squibb on 18 November 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.

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