The new application was based on results from the Phase III SCOUT-HCM trial.
Camzyos is currently approved for symptomatic NYHA Class II-III oHCM in adults to improve functional capacity and symptoms. Credit: NMK-Studio / Shutterstock.com.
The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) supplemental new drug application (sNDA) for Camzyos (mavacamten) to treat adolescents aged 12 to under 18 years with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
The regulator granted the application priority review for this indication, assigning a Prescription Drug User Fee Act (PDUFA) date of 30 September 2026. Discover B2B Marketing That Performs
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