The agency accepted 2 Supplemental New Drug Applications (sNDA) related to 2 different transplant populations.
The FDA has accepted 2 sNDAs for Merck’s letermovir (Prevymis) for Kidney Transplant and allogeneic hematopoietic stem cell transplant (HSCT) recipients.
The former sNDA is indicated for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk. The FDA has set the Prescription Drug User Fee Act (PDUFA) date for June 5, 2023.
The filing is supported by phase 3 clinical trial results that demonstrated non-inferior efficacy and a more favorable safety profile for Prevymis compared to the current standard of care for CMV prophylaxis in kidney transplant patients.
“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,” Nicholas Kartsonis, MD, senior vice president, vaccines and infectious diseases, Global Clinical Development, Merck Research Laboratories, said in a statement.
A second sNDA was included and indicated 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. A PDUFA date was set for September 7.
The sNDA for 200 days of prophylaxis with Prevymis is supported by a phase 3, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of extending prophylaxis with Prevymis from 100 to 200 days, compared to placebo, in CMV-seropositive recipients [R+] at high risk for clinically significant CMV infection following an HSCT.
Prevymis is the only drug approved in the United States for prophylaxis of CMV infection and disease in adults who are CMV-seropositive and have received an allogeneic HSCT.
The therapy has also been approved internationally in more than 60 countries including EU member states, Canada, Japan, and China.
“We look forward to the FDA’s review of our filings for Prevymis,” Kartsonis, said.