US pharmaceutical company Merck & Co Inc (NYSE:MRK), known as MSD outside the US and Canada, announced on Tuesday that the US Food and Drug Administration (FDA) has approved a new indication for PREVYMIS (letermovir) for the prophylaxis of cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients.

This approval specifically applies to patients who are CMV-seronegative recipients of a kidney from a CMV-seropositive donor.

PREVYMIS, an antiviral agent, was initially approved in 2017 for CMV infection and disease prophylaxis in CMV-seropositive recipients of an allogeneic haematopoietic stem cell transplant (HSCT). It can be administered orally or through intravenous infusion.

The FDA approval was based on a Phase 3 trial involving 589 adult kidney transplant recipients, which demonstrated non-inferiority to valganciclovir, the current standard of care, in preventing CMV disease through Week 52 post-transplant.

Merck, through a subsidiary, purchased worldwide rights to develop and commercialise letermovir from AiCuris GmbH & Co KG under an agreement signed in 2012.