BMS’ Camzyos (mavacamten) Receives EC’s Approval for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy
- The EC has approved Camzyos (2.5mg, 5mg, 10mg, 15mg capsules) for symptomatic (NYHA, class II-III) obstructive HCM. The approval was based on the 2 P-III trials of Camzyos in 251 & 112 patients
- Both trials met their 1EPs & 2EPs. In (EXPLORER-HCM) trial, 37% achieved composite 1EPs, change from baseline post-exercise LVOT peak gradient; pVO2, improvement of NYHA class ≥1 (65% vs 31%), change from baseline in KCCQ-23 CSS & HCMSQ SoB domain score
- The (VALOR-HCM) trial showed a reduction in composite 1EPs, 82% were no longer eligible for a surgical procedure or not to proceed with SRT after 16wks., 17.9% vs 76.8% proceed with SRT before or at 16wk. or were SRT eligible. In the 2EPs, change from baseline post-exercise LVOT peak gradient, NYHA class improvement of at least 1 class (62.5% vs 21.4%), change from baseline in KCCQ-23 CSS; NT-proBNP & Cardiac Troponin
Ref: Bristol Myers Squibb | Image: Bristol Myers Squibb
Related News:- BMS Receives the US FDA’s Approval of Camzyos (mavacamten) sNDA for Label Update to Treat Symptomatic Obstructive HCM
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