FDA Extends Decision Date for BMS’ Heart Disease Drug, Mavacamten

The FDA has pushed back its decision date for Bristol Myers Squibb’s (BMS) mavacamten, an experimental treatment for patients suffering from symptomatic obstructive hypertrophic cardiomyopathy — a cardiovascular disease marked by an abnormally thick heart muscle.

The FDA has extended the company’s Prescription Drug User Fee Act-mandated target decision date to April 28, 2022, giving the agency more time to review the new drug application and evaluate updates to the proposed risk evaluation and mitigations strategy.

BMS said no further studies or data have been requested by the agency.

“We are confident in the profile of mavacamten,” said Samit Hirawat, BMS’ chief medical officer for global drug development, adding that the drug improved symptoms, functional status and quality of life for patients in a late-stage trial.