The European Commission has approved the cardiac myosin inhibitor mavacamten (Camzyos) for adults with obstructive hypertrophic cardiomyopathy (OHCM) and NYHA class 2-3 symptoms, Bristol Myers Squibb has announced.

The approval in the European Union is supported by positive outcomes in both the EXPLORER-HCM and VALOR-HCM randomized controlled rials. In EXPLORER-HCM, OHCM patients on the drug vs placebo showed significant improvements in symptoms and functional status after 30 weeks.

Improvements on the drug in VALOR-HCM in patients who had been referred for septal reduction surgery were such that fewer of those on active therapy vs placebo still qualified for the procedure at 16 weeks.

Mavacamten was approved in the United States in April 2022 for NYHA class 2-3 patients with OHCM based on EXPLORER-HCM; the results of VALOR-HCM were added to its labeling earlier this month.

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