Bristol Myers Squibb announces that the European Commission has approved CAMZYOS® for the treatment of symptomatic hypertrophic obstructive cardiomyopathy in adult patients. CAMZYOS is the first and only reversible and allotropic Selective Cardiac Myosin Inhibitor approved in all Member States of the European Union* and the first Cardiac Myosin Inhibitor targeting Basic pathophysiology of HCM. CAMZYOS’s CE approval is based on positive safety and efficacy results from two Phase 3 trials, EXPLORER-HCM and VALOR-HCM.
Symptomatic obstructive HCM is a commonly inherited heart disease that can be a chronic, debilitating, progressive condition in which patients may experience symptoms of shortness of breath, dizziness, and fatigue, as well as serious, life-changing complications, including heart failure, arrhythmias, stroke, and in rare cases (~1%), sudden cardiac death.“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.”
Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb.
“Obstructive HCM is a life-changing disease for many patients who suffer from symptoms that can significantly impact their quality of life. The positive results of both Phase 3 clinical trials showed that CAMZYOS demonstrated efficacy across all primary and secondary endpoints, including improvements in exercise capacity and symptom burden for these patients,”
“As the lead clinical investigator for EXPLORER-HCM, I am grateful to the patients who played a key role in this approval and look forward to having CAMZYOS available to patients in the EU who have long awaited a new treatment option for this chronic disease.”
Iacopo Olivotto, M.D., Professor of Cardiology at the University of Florence and Head of Cardiology at Meyer Children’s Hospital, Florence, Italy.
