CAMZYOS is the first and only cardiac myosin inhibitor approved in the European Union

Approval based on two positive Phase 3 trials, EXPLORER-HCM and VALOR-HCM, demonstrating significant benefit in patients treated with CAMZYOS versus placebo

“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,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “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 where patients may experience symptoms of shortness of breath, dizziness and fatigue as well as serious, life-altering complications, including heart failure, arrhythmias, stroke and in rare cases (~1%), sudden cardiac death.

“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,” said Iacopo Olivotto, M.D., Professor of Cardiology at the University of Florence and Head of Cardiology at Meyer Children's Hospital, Florence, Italy. “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.”

Please see important safety information, including Boxed WARNING, from the U.S. prescribing information below.

Bristol Myers Squibb thanks the patients and investigators involved in both clinical trials.

*Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland, Wales).