Health Canada Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients


KIRKLAND, QC, April 19, 2024 Merck (NYSE: MRK), 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-]).

“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.”

Phase 3 study for PREVYMIS in high-risk adult kidney transplant recipients [CMV D+/R-]

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

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We 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. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information about our operations in Canada, visit and connect with us on YouTube and X (formally known as Twitter) @MerckCanada.

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Please see the product monograph for PREVYMIS® (letermovir) at: PREVYMIS-PM_E.pdf (

PREVYMIS® is a registered trademark of Merck Sharp & Dohme LLC. Used under license.
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