Camzyos is an allosteric and reversible inhibitor that works by modulating the number of myosin heads that can enter actin states, thus reducing the probability of systolic and diastolic cross-bridge formation, to target the underlying pathophysiology of HCM
BMS secures EC approval for Camzyos. (Credit: James Yarema on Unsplash)
Bristol Myers Squibb (BMS) has received the European Commission (EC) approval for Camzyos (mavacamten) to treat symptomatic obstructive hypertrophic cardiomyopathy (HCM) in adults.
Camzyos is an allosteric and reversible inhibitor that selectively blocks cardiac myosin to target the underlying pathophysiology behind HCM.
It works by modulating the number of myosin heads that can enter actin states, thus reducing the probability of systolic and diastolic cross-bridge formation.
The drug is indicated for improving functional capacity and symptoms of symptomatic New York Heart Association (NYHA) class II-III obstructive HCM in adult patients.
Camzyos is the first and only cardiac myosin inhibitor approved in the US, and is also approved in Australia, Canada, Brazil, Switzerland, Macau, South Korea, and Singapore, said BMS.
Bristol Myers Squibb chief medical officer Samit Hirawat said: “This approval marks an important milestone for patients in Europe who will now have a therapeutic option in Camzyos, a first-in-class cardiac myosin inhibitor that treats the underlying pathophysiology of symptomatic obstructive HCM.
“We’re proud to bring this innovative treatment to more patients around the world, while reinforcing our ongoing dedication to transforming patients’ lives through science on a global scale.”
Symptomatic obstructive HCM is an often-inherited heart disease that can be a chronic, debilitating, and progressive condition.
Its symptoms include shortness of breath, dizziness, and fatigue, along with serious complications, such as heart failure, arrhythmias, stroke and sudden cardiac death.
The EC approval of Camzyos is based upon positive efficacy and safety results from two Phase 3 clinical trials, EXPLORER-HCM and VALOR-HCM.
EXPLORER-HCM is a double-blind, randomized, placebo-controlled, parallel-group Phase 3 trial, which enrolled 251 adult patients with NYHA class II or III obstructive HCM.
In the study, 37% of patients taking Camzyos achieved an improvement of mixed venous oxygen tension (pVO2) compared to 17% with a placebo, which is the composite primary endpoint.
VALOR-HCM is a randomised, double-blind, placebo-controlled, multicenter Phase 3 study in 112 patients with symptomatic, obstructive HCM (NYHA class II-IV).
Its primary endpoint was a composite of the proportion of patients who decided to proceed with SRT prior to or at Week 16 or who remained eligible for SRT guidelines at Week 16.
Key secondary endpoints included the change from baseline on exercise gradient LVOT, NYHA Class and Kansas City Cardiomyopathy Questionnaire (KCCQ) and biomarkers at Week 16.
Both the Phase 3 clinical trials met all primary and secondary endpoints with statistical significance, said the US drugmaker.