The European Commission (EC) has granted marketing authorization for Prevymis (letermovir) as an orphan medicinal product for prophylaxis (prevention) of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
HSCT can be a life-saving treatment for more than 70 different diseases including leukemia, lymphoma, sickle cell anaemia. CMV infection is a common clinically significant complication in these patients and reactivation after transplant is associated with serious complications and increased mortality.
EC authorization of Prevymis allows for marketing in all 28 European Union member states, as well as European Economic Area members, Iceland, Liechtenstein and Norway. The Merck & Co drug was authorized in the USA in November 2017.