Merck gets USFDA priority review for PREVYMIS for Prophylaxis of Cytomegalovirus Disease in kidney transplant recipients at high risk

Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental new drug applications (sNDA) for PREVYMIS (letermovir).

The FDA granted priority review for the sNDA for PREVYMIS for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (D+/R-); the Prescription Drug User Fee Act (PDUFA), or target action date, is June 5, 2023. The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition. A second sNDA to extend use of PREVYMIS from 100 days 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 accepted for review, with a PDUFA date of Sept. 7, 2023.