U.S. Food and Drug Administration Approves Expanded Indication for Bristol Myers Squibb’s CAMZYOS® (mavacamten) for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) in Adults and Pediatric Patients*
Business Wire•30/09/2026•17:32 ET
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Key Highlights
- ➤FDA approves CAMZYOS (BMY) for symptomatic oHCM in adults and pediatric patients weighing 30 kg or more
- ➤CAMZYOS (BMY) becomes the only FDA-approved therapy for pediatric oHCM
- ➤CAMZYOS (BMY) now has the broadest indication among cardiac myosin inhibitors
- ➤Approval is based on positive results from Phase 3 SCOUT-HCM trial
Expert Statements
Al Reba, Senior Vice President, Immunology & Cardiovascular Commercialization, Bristol Myers Squibb
“Today’s approval of CAMZYOS for pediatric patients with symptomatic obstructive hypertrophic cardiomyopathy marks an important milestone for young patients and families who are facing a serious cardiovascular disease with significant unmet medical need. For young patients living with this disease, the burden on daily life can be substantial during a critical stage of development, and we are proud to help bring an innovative new treatment option to this community. This approval also strengthens the growing body of clinical evidence supporting CAMZYOS, which is the most extensively studied cardiac myosin inhibitor with up to five years of follow up in adults, and its role in the treatment of oHCM.”
U.S. Food and Drug Administration Approves Expanded Indication for Bristol Myers Squibb’s CAMZYOS(®) (mavacamten) for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) in Adults and Pediatric Patients*
CAMZYOS is the only FDA-approved therapy for the treatment of oHCM in a pediatric population
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