Bristol Myers Squibb: Camzyos mavacamten supplemental New Drug Application (sNDA) accepted by the U.S. FDA.
On June 1, local time, Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) seeking approval for Camzyos (mavacamten) for the treatment of adolescent patients (aged 12 to under 18 years) with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
According to the press release, if approved, Camzyos would become the first cardiac myosin inhibitor (CMI) indicated for the treatment of adolescent patients with oHCM. The FDA has granted Priority Review for this application and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 30, 2026. Previously, Camzyos has been approved for the treatment of adults with symptomatic oHCM (New York Heart Association [NYHA] functional class II-III) to improve functional capacity and symptoms.
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