Health Canada approves new indication for Merck’s Prevymis for prevention of CMV disease in high-risk adult kidney transplant recipients
Overview
Merck, 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-]).
Words from Merck Canada
- “We are pleased that Prevymis has received Health Canada approval to help prevent CMV disease in high-risk adult kidney transplant patients.” said Philippe Houle, executive director of infectious diseases and specialty medicines at Merck Canada.
- “Our focus remains solely on providing innovative medicines to address the unmet needs of all Canadians.”
Trial Behind Approval
- Health Canada’s approval of Prevymis for CMV disease prophylaxis in adult kidney transplant recipients was supported by a phase 3, 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.
About Merck
- Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: The company use the power of leading-edge science to save and improve lives around the world.
- For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines.
