FDA accepts Bristol Myers Squibb Camzyos application for adolescent treatment

The U.S. Food and Drug Administration has accepted Bristol Myers Squibb's (NYSE: BMY) supplemental new drug application for Camzyos (mavacamten) to treat adolescents aged 12 to under 18 years with symptomatic obstructive hypertrophic cardiomyopathy.

The FDA granted priority review status to the application and assigned a Prescription Drug User Fee Act date of September 30, 2026. If approved, Camzyos would become the first cardiac myosin inhibitor approved for treating this condition in adolescents.

The application was based on data from the Phase 3 SCOUT-HCM trial, which enrolled 44 adolescent patients and met its primary endpoint. The trial demonstrated a reduction from baseline in Valsalva left ventricular outflow tract gradient at week 28 compared to placebo. The safety profile in adolescents was similar to that reported in adults, with no patients experiencing left ventricular ejection fraction below 50%.

Camzyos is currently approved for treating adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms. The drug has been prescribed by more than 4,500 healthcare providers to almost 25,000 patients in the United States.

The SCOUT-HCM trial results were presented at the American College of Cardiology Annual Scientific Session & Expo 2026 and published simultaneously in The New England Journal of Medicine.

Obstructive hypertrophic cardiomyopathy in adolescents causes substantial morbidity related to reduced exercise tolerance. Current treatments have limitations for adolescent patients, including side effects from beta-blockers and risks associated with invasive procedures.

You May Also Be Interested In

• Mizuho Starts Sol Gel Technologies Ltd. (SLGL) at Outperform
• JPMorgan Downgrades Wipro Ltd. (WPRO:IN) (WIT) to Underweight
• Agomab outlines Phase 2b trial design for Crohn's disease drug