FDA expands Camzyos heart treatment to children
The FDA has approved Camzyos for symptomatic obstructive hypertrophic cardiomyopathy in children weighing at least 30 kg, extending a treatment that requires monitoring for heart failure.
The FDA has expanded the approval of Camzyos, or mavacamten, to children weighing at least 30 kg with symptomatic obstructive hypertrophic cardiomyopathy.
In this inherited condition, thickened heart muscle can narrow the passage through which blood leaves the heart. The September 30 decision gives pediatric cardiologists an approved drug option intended to improve symptoms and physical function.
The direct pediatric evidence comes from SCOUT-HCM, a randomized, blinded trial of 44 adolescents aged 12 to under 18. After 28 weeks, the estimated reduction in the pressure gradient across the narrowed outlet was 48 mm Hg greater with mavacamten than placebo; the 95% confidence interval was 28.3–67.7 mm Hg greater reduction. This measures relief of obstruction. It does not establish longer survival.
The September prescribing information combines the adolescent results with adult evidence and drug-exposure data to support the weight-based indication. It also retains a boxed warning: reducing heart contraction too far can cause heart failure. Echocardiograms are required before and during treatment, and the medicine remains restricted to a risk-management programme. For affected families, the practical next step is a discussion with their pediatric cardiology team about eligibility, interactions and monitoring.
Take it further
Read the updated label with your care team For families affected by symptomatic obstructive HCM. Pediatric eligibility starts at 30 kg; specialist assessment, interaction checks and required cardiac monitoring still apply. No application deadline.
Sources & details 5 sources
Discuss in your voice app
Take the reporting, visual explanations and original sources into a conversation. Copy the brief, paste it into your preferred assistant, then start its voice mode.
Paste the brief into your voice app to discuss this reporting.Revised 4 October 2026. Reporting and visuals refined. Original source dates and prior checks retained.
Reporting sources
- FDA — pediatric Camzyos approval
FDA's drug-news index dates this announcement September 30, 2026. Confirms indication, adolescent evidence and boxed warning.
- FDA — September 30 drug-news index
Original FDA listing establishes the announcement date, checked October 1, 2026.
- Camzyos — approved prescribing information
Revised September 2026, reference ID 5877752; indication and warning on pages 1–2, pediatric evidence on pages 13 and 28–29. Original PDF hosted by the manufacturer.
- SCOUT-HCM — peer-reviewed trial abstract
Rossano et al., NEJM; online March 29, 2026, journal issue July 23. DOI 10.1056/NEJMoa2601103. 44 randomized participants, 28-week comparison; publisher full text was not accessible.
- Bristol Myers Squibb — September 30 approval and data
Manufacturer's dated announcement and trial table corroborate the current label. Promotional claims are not treated as independent evidence.
Images & figures
SCOUT-HCM at 28 weeks. Bars show the magnitude of observed mean decreases in Valsalva LVOT gradient; the second view shows the adjusted difference and its 95% confidence interval. This is a pressure measurement, not a survival estimate.
September 2026 prescribing information · SCOUT-HCM