U.S. FDA Accepts for Priority Review the Supplemental New Drug Application for PREVYMIS™
Friday, February 17, 2023
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. A second sNDA to extend use of PREVYMIS from 100 days to 200 days in adults receiving an allogeneic haematopoietic 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.
PREVYMIS is a first-in-class antiviral agent 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 haematopoietic stem cell transplant (HSCT).
PREVYMIS is the only drug approved in the United States for prophylaxis of CMV infection and disease in adults consisting of CMV-seropositive and received an allogeneic HSCT. PREVYMIS is also approved in more than 60 countries outside of the United States, including EU member states, Canada, Japan and China. PREVYMIS is a first-in-class non-nucleoside CMV inhibitor (3,4 dihydro-quinazolines) and inhibits viral replication by specifically targeting the viral terminase complex. Cross resistance is not likely with drugs outside of this class. PREVYMIS is fully active against viral populations with substitutions conferring resistance to CMV DNA polymerase inhibitors. These DNA polymerase inhibitors are fully active against viral populations with substitutions conferring resistance to PREVYMIS. PREVYMIS has no activity against other viruses.
In the study, PREVYMIS had a more favourable safety profile compared to valganciclovir, with fewer drug-related adverse events (AEs) and study drug discontinuations due to adverse events reported in the PREVYMIS group compared to the valganciclovir group.
