FDA Begins Review of Bristol Myers Squibb’s Mavacamten for oHCM

The FDA has accepted Bristol Myers Squibb’s New Drug Application (NDA) for mavacamten, an experimental cardiac drug meant to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM) — an incurable condition caused by thickening of heart muscle that blocks blood flow.

The submission is supported by phase 3 trial results showing the drug improved the heart’s function, eased symptoms and helped alleviate obstruction in the heart’s left ventricle.

Mavacamten is believed to work by inhibiting certain motor proteins and targeting a molecular defect associated with the disease, which can be chronic and progressive.

The FDA has set a target decision date for the NDA of Jan. 28, 2022.