News | Pharmaceuticals | June 28, 2023

Bristol Myers Squibb Receives European Commission Approval of CAMZYOS (mavacamten), for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (HCM)

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

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

June 28, 2023 — Bristol Myers Squibb announced that the European Commission (EC) has approved CAMZYOS (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM) in adult patients. CAMZYOS is the first and only allosteric and reversible inhibitor selective for cardiac myosin approved in all European Union (EU) member states* and is the first cardiac myosin inhibitor that targets the underlying pathophysiology of HCM. The EC approval of CAMZYOS is based upon positive efficacy and safety results from two Phase 3 trials, EXPLORER-HCM and VALOR-HCM. 

“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). 

Full European Summary of Product Characteristics for CAMZYOS is available from the EMA website atwww.ema.europa.eu

For more information: www.bms.com


Related Content

News | Cardiovascular Clinical Studies

July 18, 2024 — Elucid, a pioneering AI medical technology company providing physicians with imaging analysis software ...

Home July 18, 2024
Home
News | Cardiovascular Clinical Studies

July 10, 2024 — CellProthera, a private company specializing in cell-based therapies for repairing ischemic tissues, and ...

Home July 10, 2024
Home
News | Cardiovascular Clinical Studies

July 9, 2024 — Microbot Medical Inc. announced the completion of the first procedure in a patient utilizing its LIBERTY ...

Home July 09, 2024
Home
News | Cardiovascular Clinical Studies

June 26, 2024 — Semaglutide, a medication initially developed for type 2 diabetes and obesity, significantly improves ...

Home June 26, 2024
Home
News | Cardiovascular Clinical Studies

June 21, 2024 — Lexicon Pharmaceuticals, Inc. announced that the peer-reviewed Journal of the American College of ...

Home June 21, 2024
Home
News | Cardiovascular Clinical Studies

June 20, 2024 — Microbot Medical Inc. announced its agreement with Brigham and Women’s Hospital (BWH), a leading ...

Home June 20, 2024
Home
News | Cardiovascular Clinical Studies

June 20, 2024 — A programming algorithm, being tested by HonorHealth Research Institute for those patients with new or ...

Home June 20, 2024
Home
Videos | Cardiovascular Clinical Studies

As part of DAIC's continuing Thought Leadership Series, this month Editorial Director Melinda Taschetta-Millane sits ...

Home June 12, 2024
Home
News | Cardiovascular Clinical Studies

June 6, 2024 —Cleveland Clinic researchers found higher amounts of the sugar alcohol xylitol are associated with ...

Home June 06, 2024
Home
Subscribe Now