FDA Accepts for Priority Review the Supplemental New Drug Application for Merck’s PREVYMIS for Prophylaxis of Cytomegalovirus Disease in Kidney Transplant Recipients at High Risk

Merck, known as MSD outside of the United States and Canada, announced 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.

“Certain high-risk individuals who develop CMV infection following receipt of a kidney transplant are at increased risk for transplant failure and death. PREVYMIS has the potential to be an important new option with a favorable safety profile for patients at risk for CMV infection following a kidney transplant,” said Dr. Nicholas Kartsonis, senior vice president, vaccines and infectious diseases, Global Clinical Development, Merck Research Laboratories. “We look forward to the FDA’s review of our filings for PREVYMIS.”

PREVYMIS is a first-in-class antiviral agent that was approved by the U.S. FDA in 2017 and is indicated for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).