By IDSE News Staff
The FDA accepted for Priority Review a supplemental New Drug Application (sNDA) for letermovir (Prevymis, Merck) as prophylaxis against cytomegalovirus (CMV) in adult kidney transplant recipients at high risk (D+/R-); the Prescription Drug User Fee Act (PDUFA) date is June 5.
A second sNDA to extend use of letermovir from 100 to 200 days in adults receiving an allogeneic hematopoietic stem cell transplant (HSCT) who are at risk for late CMV infection and disease was also