29 April 2022 - - The US Food and Drug Administration approved Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms, US-based pharmaceutical company Bristol Myers Squibb (NYSE: BMY) said.

Camzyos is the first and only FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of obstructive HCM.

This approval is based on data from the Phase 3 EXPLORER-HCM trial. At baseline, approximately 73% of the randomized patients were NYHA class II and 27% were NYHA class III. The mean LVEF was 74%, and the mean Valsalva left ventricular outflow tract gradient was 73 mmHg.

The baseline mean Kansas City Cardiomyopathy Questionaire-23 (KCCQ-23) Clinical Summary Score was 71.

At Week 30, 37% (n=45/123) of patients taking Camzyos achieved the composite primary endpoint, defined as the proportion of patients who achieved either improvement of mixed venous oxygen tension by ≥1.5 mL/kg/min plus improvement in NYHA class by at least 1 or improvement of pVO2 by ≥3.0 mL/kg/min plus no worsening in NYHA class, versus 17% (n=22/128) treated with placebo.

The difference was 19% (95% CI: 9, 30; p=0.0005).

In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the Camzyos group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%). Mean resting LVEF was 74% (6) at baseline in both treatment groups.

Mean absolute change from baseline in LVEF was -4% (8) in the Camzyos group and 0% (7) in the placebo group over the 30-week treatment period.

At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups.

Additionally, seven patients in the Camzyos group and 2 patients in the placebo group experienced reversible reductions in LVEF to