FDA expands Camzyos approval to paediatric patients with obstructive hypertrophic cardiomyopathy
The FDA has expanded Camzyos approval to paediatric patients with symptomatic obstructive hypertrophic cardiomyopathy who weigh at least 30kg.
Camzyos (mavacamten) is now approved to improve functional capacity and symptoms in both adults and eligible paediatric patients with obstructive hypertrophic cardiomyopathy.
The expansion, supported by the Phase III SCOUT-HCM study, extends cardiac myosin inhibition into a younger patient population with this inherited heart condition.
Field | Content |
Article Type | Approvals |
Drug Name | Mavacamten |
Brand Name | Camzyos |
Company | Bristol Myers Squibb |
Regulatory Authority | U.S. Food and Drug Administration |
Approval Type | Indication expansion |
Indication | Symptomatic obstructive hypertrophic cardiomyopathy |
Patient Population | Adults and paediatric patients weighing at least 30kg |
Therapy Areas | Cardiology; hypertrophic cardiomyopathy |
Technology/Modality | Cardiac myosin inhibitor |
Clinical Study | Phase III SCOUT-HCM |
Geography | United States |
What Happened | The FDA expanded Camzyos approval to eligible paediatric patients with symptomatic obstructive hypertrophic cardiomyopathy. |
Why It Matters | The decision extends a disease-specific therapy for oHCM into a paediatric population with limited targeted treatment options. |
Supporting Context | Bristol Myers Squibb describes Camzyos as the only FDA-approved therapy for oHCM in a paediatric population. |
Potential Impact | The label expansion broadens access to cardiac myosin inhibition for younger patients meeting the weight and disease criteria. |
Key Takeaway | Camzyos is now FDA approved for symptomatic oHCM in adults and eligible paediatric patients. |
What to Watch | Paediatric uptake, guideline integration and longer-term safety and effectiveness data from younger patients. |
Primary Source | Bristol Myers Squibb |
Relevant Date | 30 September 2026 |
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