FDA OKs Merck’s Prevymis for Kidney Transplants

FDA has approved Merck’s Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients. The antiviral agent was originally approved in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant. It is administered once daily as an oral tablet or as an injection for intravenous infusion.

Approval was based on data from a Phase 3 active comparator-controlled non-inferiority trial in 589 adult kidney transplant recipients. The study demonstrated that Prevymis was non-inferior to valganciclovir, the current standard of care, for the primary endpoint of incidence of CMV disease, the company says. “The proportion of study participants with CMV disease through Week 52 post-kidney transplant was 10% with Prevymis and 12% with valganciclovir,” it says.