Health Canada approves new indication for Prevymis (letermovir) for prevention of cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients – Merck

Merck Inc. known as MSD outside of the United States and Canada, announced that Health Canada has approved a new indication for Prevymis (letermovir) for the prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]).

Health Canada’s approval of Prevymis for CMV disease prophylaxis in adult kidney transplant recipients was supported by a Phase III, randomized, multicenter, double-blind, active comparator-controlled non-inferiority trial (P002, NCT03443869) in 589 adult kidney transplant recipients at high risk (CMV D+/R-). Participants were randomized (1:1) to receive either Prevymis concomitantly with acyclovir (n=292), or valganciclovir concomitantly with a placebo to acyclovir (n=297). Study drug was initiated between Day 0 and Day 7 post-kidney transplant and continued through Week 28 (~200 days) post-transplant. Study drug was administered either orally or IV; the dose of Prevymis was the same regardless of the route of administration.