Merck, referred as MSD outside the US and Canada, has confirmed that Health Canada has approved a new indication for PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high risk adult kidney transplant recipients.
This approval is for cases where the donor is CMV-seropositive or the recipient is CMV-seronegative (D+/R-).
The decision by Health Canada was based on the results of a Phase III, double-blind, multi-centre, randomised, active comparator-controlled non-inferiority trial.
The trial, which is identified as P002 (NCT03443869), included 589 adult kidney transplant recipients identified as high risk (CMV D+/R-).
As part of the Phase III trial, participants were randomised in a one-to-one ratio to receive either PREVYMIS alongside acyclovir (n=292), or valganciclovir with a placebo to acyclovir (n=297).
Merck said that the study medication was initiated between Day 0 and Day 7 following the kidney transplant and was continued through Week 28, which is approximately 200 days after the transplant.
PREVYMIS was administered either orally or intravenously, with the dosage remaining consistent regardless of the administration route.
Merck Canada Infectious Diseases and Specialty Medicines executive director Philippe Houle said: “We are pleased that PREVYMIS has received Health Canada approval to help prevent CMV disease in high-risk adult kidney transplant patients.
“Our focus remains solely on providing innovative medicines to address the unmet needs of all Canadians.”
The company describes PREVYMIS as an antiviral agent that was initially approved by the US Food and Drug Administration (FDA) in 2017 for the prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
It is taken once daily, either as an oral tablet or as an injection for intravenous infusion.
In June 2023, Merck received approval from the US FDA for PREVYMIS for the same indication of CMV disease prophylaxis in adult kidney transplant recipients at high risk, after a priority review.