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23 Apr 2024
Admin
News Article

Health Canada Approves New Indication for Merck’s Prevymis

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.

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