The European Commission (EC) has granted approval for Bristol Myers Squibb’s (BMS) Camzyos (mavacamten, 2.5mg, 5mg, 10mg, 15mg capsules) to treat adults with symptomatic (New York Heart Association class II-III) obstructive hypertrophic cardiomyopathy (HCM).
Camzyos is the first and only cardiac myosin-selective allosteric and reversible inhibitor to obtain approval in all member states in the European Union (EU).
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It is also the first cardiac myosin inhibitor that acts on HCM’s underlying pathophysiology.
The EC’s approval is based on the positive safety and efficacy data from the Phase III EXPLORER-HCM and VALOR-HCM trials.
Camzyos is currently approved for use in the US, Canada, Australia, South Korea, Singapore, Switzerland, Brazil and Macau.
BMS chief medical officer Samit Hirawat stated: “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.
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By GlobalData“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.”
This month, the company received US Food and Drug Administration approval to begin commercial operations at its cell therapy manufacturing facility in Devens, Massachusetts, US.
