US FDA expands approval for Merck’s PREVYMIS (letermovir)
The FDA approval was supported by a double-blind, active comparator-controlled non-inferiority Phase III trial.
The US Food and Drug Administration (FDA) has granted approval for a new indication for Merck’s PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients.
The latest move follows a priority review of a supplemental new drug application (sNDA) for the therapy.
In 2017, the therapy received FDA approval for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.
The drug is given once a day as an oral tablet or as an injection for intravenous infusion.
Merck Research Laboratories global clinical development vice-president Dr Elizabeth Rhee stated: “PREVYMIS has been an important addition to the care of high-risk adult CMV-seropositive patients who have received allogeneic stem cell transplants to help prevent CMV infection and disease.
“We are delighted that PREVYMIS is now approved to help prevent CMV disease in adult kidney transplant patients at high risk.
“At Merck, we are proud to continue to bring innovative medicines to people to address serious infectious diseases.”
The regulatory approval was supported by a double-blind, randomised, multicentre, active comparator-controlled non-inferiority Phase III trial conducted in 589 adult kidney transplant recipients at high risk of CMV.
The trial’s main objective was to assess the efficacy of letermovir against valganciclovir (VGCV).
PREVYMIS was found to be superior to valganciclovir in terms of the primary endpoint of incidence of CMV disease through to week 52 following kidney transplantation.
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