Posted by Michael Wonder on 19 Mar 2021
U.S. FDA accepts Bristol Myers Squibb’s application for mavacamten in symptomatic obstructive hypertrophic cardiomyopathy
19 March 2021 - Application based on results from the Phase 3 EXPLORER-HCM trial.
Bristol Myers Squibb today announced that the U.S. FDA has accepted its new drug application for mavacamten, an investigational, novel, oral, allosteric modulator of cardiac myosin, for patients with symptomatic obstructive hypertrophic cardiomyopathy.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of 28 January 2022.
