CHMP positive for Prevymis (letermovir) for prophylaxis of cytomegalovirus disease in adult kidney transplant recipients at high risk.- Merck Inc.,
Merck Inc., known as MSD outside of the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]).
The CHMP has also recommended the approval for extending dosing for Prevymis from 100 days to 200 days following transplant in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) who are at risk for late CMV infection and disease.
The CHMP’s recommendations will now be reviewed by the European Commission for marketing authorization in the European Union (EU) and a final decision is expected this year.
.Prevymis is an antiviral agent that was initially approved by the FDA in 2017 and by the EMA in 2018 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic HSCT. In June 2023, the FDA approved Prevymis for prophylaxis of CMV disease in adult kidney transplant recipients at high risk, and in August 2023, the FDA approved extended 200-day dosing for Prevymis for CMV prophylaxis in HSCT recipients at risk for late CMV infection and disease.
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