Merck's Letermovir Receives Clinical Approval in China for Prevention and Treatment of Cytomegalovirus Infection

Text | Baihuawen

On June 8, MSD’s letermovir injection/tablets received clinical trial approval in China for the prevention of cytomegalovirus (CMV) reactivation and disease in adult allogeneic hematopoietic stem cell transplantation (HSCT) recipients who are CMV-seropositive [R+]. The drug was approved by the FDA for marketing on November 8, 2017, under the brand name Prevymis, becoming the first medication approved in the United States in nearly 15 years for the treatment of cytomegalovirus.

Cytomegalovirus (CMV) is a DNA virus belonging to the herpesvirus family. CMV infection is common in the general population and is typically mild or asymptomatic in clinical presentation; however, in individuals with severe immunosuppression, it can invade multiple organs and systems, leading to serious consequences and even life-threatening conditions.

Letermovir is a potent CMV DNA terminase inhibitor that primarily targets the pUL56 subunit, thereby inhibiting viral replication to achieve therapeutic efficacy. Clinical studies have demonstrated that letermovir exhibits a favorable safety and efficacy profile; after 28 days of treatment, cytomegalovirus was undetectable in patients, and no cross-resistance with other approved drugs was observed.