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).
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.
“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.