BMY was granted approved on 28Apr2022 for Camzyos/Mavacamten as a First-in-Class (FIC) myosin inhibitor for the treatment of obstructive hypertrophic cardiomyopathy (oHCM). Given the REMS requirement, education and certification of cardiologists, payer/formulary negotiations, appropriate guidance for a gradual launch were provided. Encouraging progress has been made per the Cardiovascular (C) slide from 4Q2022 earnings presentation:
Impressive sequential growth in REMS certified physicians, patients in hub and patients on commercial drug portend strength into 2023 with additional long term drivers from European approval expected midyear 2023 and a minor Life Cycle Management (LCM) opportunity based on the VALOR study with a 16Jun2023 PDUFA date.
The American College of Cardiology Annual Conference (ACC23) provided an excellent opportunity to build upon earlier data with longer 96 week term efficacy, Long Term Extension (LTE), Real World Experience (RWE), further articulation of subsets (Male versus Female, with and without Hypertension, Older Patients) from EXPLORER trial providing more useful information for prescribers of this FIC therapeutic.
Here are some of the posters BMY highlighted: