Merck & Co., Inc. (MRK.US) intends to include Zeltema tablets in the Priority Review of the CDE, a new variety for children.

Today, the official website of the China National Medical Products Administration Drug Evaluation Center (CDE) has just announced that the Merck & Co., Inc. (MSD) (MRK.US) -submitted Letermovir tablets are set to be included in priority review for use in preventing cytomegalovirus (CMV) infection and CMV disease in adult and pediatric recipients [R+] who are CMV seropositive and undergoing allogeneic hematopoietic stem cell transplantation (HSCT), and are at least 6 months old and weigh 6 kg. Letermovir is a new type of non-nucleoside cytomegalovirus (CMV) inhibitor, and its tablet and injection formulations have already been approved for market in China. According to the CDE announcement, Letermovir tablets are classified as a new drug for pediatric patients. Cytomegalovirus, as a widely prevalent herpes virus, poses a serious threat to the life and health of hematopoietic stem cell transplant patients. Studies have shown that the seropositivity rate for CMV in these patients can be over 90%. Although preemptive therapy is an effective method to control CMV, many allogeneic HSCT recipients still face problems with refractory CMV infection, and there are adverse reactions such as bone marrow suppression and renal toxicity with preemptive therapy drugs, which increase the risk of death and medical burden for patients.