Merck & Co.'s (MRK.US) Letermovir Microcrystal Nominated for CDE Priority Review, a New Drug for Children
1min read Today, the National Medical Products Administration's (NMPA) Center for Drug Evaluation (CDE) officially announced that merck & Co., Inc. (MRK.US) had applied for priority review for its Letermovir Microcrystal, which is intended for the prevention of cytomegalovirus (CMV) infection and disease in adult and pediatric recipients aged 6 months and older with a body weight of ≥6kg who are seropositive for CMV and have received allogeneic hematopoietic stem cell transplantation (HSCT) [R+]. Letermovir is a new non-nucleoside CMV inhibitor. The tablet and injection formulations of the product have been approved for marketing in China. According to the CDE's announcement, Letermovir Microcrystal is a new pediatric drug.
Cytomegalovirus, a widely prevalent herpes virus, poses a serious threat to the life and health of hematopoietic stem cell transplantation patients. Studies have shown that the seropositive rate of cytomegalovirus in these patients can be as high as 90% or more. Although preemptive therapy is an effective method to control CMV, many allogeneic HSCT recipients still face the problem of difficult-to-treat cytomegalovirus infection, and the preemptive therapy drugs have problems such as bone marrow suppression and renal toxicity, increasing the risk of death and medical burden for patients.