Prevymis now approved for CMV prophylaxis after kidney transplant in USA

7 June 2023

The US Food and Drug Administration (FDA) has approved a new indication for Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]) following a priority review.

Marketed by US pharma giant Merck & Co (NYSE: MRK), Prevymis is an antiviral agent that was initially approved by the FDA in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). Prevymis is administered once-daily as an oral tablet or as an injection for intravenous infusion.

Merck purchased worldwide rights to develop and commercialize letermovir from AiCuris GmbH in 2012 for around $570 million.

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