Merck's Prevymis Approved in China for Pediatric CMV Prevention

Merck & Co., Inc. announced on June 23 that its innovative cytomegalovirus (CMV) prevention drug, Prevymis® (letermovir), has received approval from the National Medical Products Administration (NMPA) for two formulations—tablets and injection—in China. This approval allows for the use of Prevymis in pediatric patients aged six months and older, weighing at least 6 kg. The complete indication is for the prevention of CMV infection and CMV disease in recipients of allogeneic hematopoietic stem cell transplantation (HSCT) who are CMV seropositive.

This milestone marks Prevymis as the first and currently the only CMV prevention regimen available in China for both adult and pediatric patients undergoing HSCT. This development provides a precise infection control option for relevant pediatric patients. Cytomegalovirus is a widely prevalent virus that can cause severe infections in immunocompromised individuals, particularly those undergoing HSCT.

The approval of Prevymis in China underscores Merck's commitment to addressing unmet medical needs in the region and expanding access to innovative therapies for patients. The drug's unique mechanism of action, which targets the viral DNA polymerase, makes it a valuable addition to the arsenal of treatments available for CMV prevention. The availability of both tablet and injection formulations provides flexibility in administration, ensuring that patients can receive the treatment that best suits their needs.

The approval of Prevymis in China is expected to have a positive impact on the management of CMV infections in pediatric patients undergoing HSCT. The drug's efficacy and safety profile, as demonstrated in clinical trials, make it a promising option for preventing CMV infections in this vulnerable population. The availability of Prevymis in China is a testament to Merck's commitment to improving patient outcomes and addressing unmet medical needs in the region.