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The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for letermovir for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (D+/R-), with a Prescription Drug User Fee Act (PDUFA) target date of June 5, 2023.
The sNDA is supported by data from a phase 3 trial (ClinicalTrials.gov Identifier: NCT03443869) that evaluated the efficacy and safety of letermovir to prevent CMV disease in 601 adult kidney transplant recipients at high risk. Patients were randomly assigned to receive either letermovir 480mg orally once (n=301) or valganciclovir 900mg orally once daily (n=300) within 7 days post-kidney transplant through 28 weeks post-transplant, with follow-up through 52 weeks
At 52 weeks, treatment with letermovir was found to be effective and noninferior to valganciclovir; 10.4% of patients in the letermovir arm developed CMV disease vs 11.8% of patients in the valganciclovir arm (stratum adjusted difference, -1.4 [95% CI, -6.5, 3.8]). A safety analysis showed that letermovir was associated with fewer drug-related adverse events and study drug discontinuations due to adverse events compared with valganciclovir. The incidence of leukopenia and neutropenia was lower in the letermovir arm vs the valganciclovir arm.
Additionally, the FDA has accepted for review a second sNDA to extend use of letermovir 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 target date of September 7, 2023 has been set for this application.
Letermovir is currently marketed under the brand name Prevymis™ for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic HSCT. “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.”
Reference
US 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. News release. Merck. Accessed February 17, 2023. https://www.merck.com/news/u-s-fda-accepts-for-priority-review-the-supplemental-new-drug-application-for-mercks-prevymis-for-prophylaxis-of-cytomegalovirus-disease-in-kidney-transplant-recipients-at-high-risk/.
