The FDA has approved Camzyos (mavacamten) capsules as the first treatment for children with symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms.
Camzyos is now approved for adults and pediatric patients weighing at least 30 kilograms (approximately 66 pounds) with symptomatic oHCM, according to a Sept. 30 FDA news release. The drug was first approved for adults in 2022.
The approval was supported by SCOUT-HCM, a phase 3 study involving 44 patients with symptomatic oHCM ages 12 to 18. Patients received Camzyos or placebo once daily for 28 weeks. Camzyos significantly reduced the Valsalva LVOT gradient compared with placebo.
Camzyos carries a boxed warning for the risk of heart failure and is available only through the Camzyos Risk Evaluation and Mitigation Strategy. Dizziness and fainting occurred in more than 5% of patients and more often among patients receiving Camzyos compared with placebo.
The drug received orphan drug designation for this indication.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
