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The US FDA has approved Camzyos (mavacamten) for the treatment of symptomatic oHCM to improve functional capacity & symptoms in adults & pediatric pts (≥30kg)
Approval was based on P-III (SCOUT-HCM) trial data assessing Camzyos (n=23) vs PBO (n=21) in 44 pts (12 to <18yrs.) with symptomatic NYHA class II-III oHCM, which met its 1EP, showing reductions in Valsalva LVOT gradient at Wk. 28 (−49.4 vs -1.8mm Hg)
In 2EPs, at wk. 28, Camzyos reduced the resting LVOT gradient by 41mm Hg vs a 5.3mm Hg increase, while Post-exercise LVOT gradient decreased by 31.2mm Hg vs a 10.5mm Hg increase. Plus, maximal LV wall thickness reduced by 2.5mm vs 0.7mm
Ref: Businesswire | Image: BMS | Press Release
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The post BMS Reports US FDA Approval of Camzyos in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) appeared first on PharmaShots.
