FDA Drug Approvals, Cardiology — 2022 Midyear Review

August 24, 2022

Camzyos (mavacamten)

Mavacamten is a first-in-class cardiac myosin inhibitor indicated for symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve exercise capacity and symptoms in adults. Mavacamten modulates the number of myosin heads that can enter “on actin” (power-generating) states, thus reducing the probability of force-producing (systolic) and residual (diastolic) cross-bridge formation. Excess myosin actin cross-bridge formation and dysregulation of the super-relaxed state are mechanistic hallmarks of HCM.

Approval of mavacamten was based on results from the multicenter, phase 3 EXPLORER-HCM trial (n = 251). Of 123 patients randomly assigned to mavacamten, 92 (75%) completed the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and week 30; and of the 128 patients randomly assigned to placebo, 88 (69%) completed the KCCQ at baseline and week 30. At 30 weeks, the change in KCCQ-OS (overall summary) score was greater with mavacamten than with placebo (mean score, 14.9 vs 5.4; difference +9.1; P<0.0001), with similar benefits across all KCCQ subscales. The proportion of patients with a very large change (KCCQ-OS 20 points or more) was 36% in the mavacamten group versus 15% in the placebo group, with an estimated absolute difference of 21%. These gains returned to baseline after treatment was stopped. Lancet. 2021 Jun 26

Other cardiology approvals

Jardiance (empagliflozin) – Indication to reduce the risk of cardiovascular death plus hospitalization in adults with heart failure (HF) broadened to include HF with either reduced or preserved ejection fraction.

Xigduo XR (dapagliflozin/metformin) – New indication approved to reduce risk of CV death and hospitalization for HF in adults with T2DM who have HF (NYHA class II-IV) with reduced ejection fraction.

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