pharmaceutical-technology.com· Pharmaceutical Technology·· 17 days agoPickScore75
Bristol Myers Squibb secures expanded US approval for Camzyos
In brief
The FDA has expanded Bristol Myers Squibb's Camzyos (mavacamten) indication to cover symptomatic obstructive hypertrophic cardiomyopathy in adults and paediatric patients weighing at least 30kg. The decision rests on the Phase III SCOUT-HCM trial in 44 adolescents aged 12 to under 18, where the cardiac myosin inhibitor significantly reduced Valsalva LVOT gradient at week 28 versus placebo with no new safety concerns. Camzyos, first approved in 2022 and now cleared in more than 60 countries, is in discussions with other regulators for paediatric approvals.
Why it matters
FDA label expansion extends a cardiac myosin inhibitor into paediatric oHCM, a setting with significant unmet need.
Source: pharmaceutical-technology.com