MSD Submits New Pediatric-Formulated Letermovir Mini-Tablets for Approval in China

Mar 08, 2025 08:49 CST Updated 08:49

MSD

Pharmaceutical R&D and Manufacturer

▎WuXi AppTec Content Team Report

Today（On March 8, the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) stated,MSD (Merck & Co., Inc.) submittedLetermovir MicrotabletsThe listing application has been accepted. A few days ago, the drug was proposed by the CDE to be included in the priority review for use inAdult recipients and pediatric recipients aged 6 months or older with a body weight ≥6kg who are cytomegalovirus (CMV) seropositive and have undergone allogeneic hematopoietic stem cell transplantation (HSCT) [R+]Prevention of Cytomegalovirus Infection and Cytomegalovirus Disease。Letermovir is a novel non-nucleoside cytomegalovirus (CMV) inhibitor. The tablet and injectable forms of this product have already been approved for marketing in China.According to the CDE announcement, letermovirMicrotabletsBelongs to a new variety for children.

Screenshot source:CDE Official Website

Cytomegalovirus, as a widely present herpesvirus, poses a serious threat to the life and health of hematopoietic stem cell transplant patients.Studies have shown that among these patients, the seroprevalence of cytomegalovirus can be as high asMore than 90%.Although preemptive therapy is an effective method for controlling CMV, many allogeneic HSCT recipients still experience refractory cytomegalovirus infection. Moreover, the drugs used in preemptive therapy can cause adverse reactions such as bone marrow suppression and nephrotoxicity, increasing the risk of mortality and healthcare burden for patients.

Public information shows,Letermovir is aNovel Non-Nucleoside CMV Inhibitor(3,4-Dihydroquinazoline). This product has a novel anti-CMV effect,By inhibiting the activity of the cytomegalovirus terminase complex, preventing the processing and packaging of viral DNA, thereby exerting an antiviral effect. The difference from DNA polymerase inhibitors lies in,Letermovir has higher selectivity for CMV and its potency is also significantly improved.。

LetermovirTabletHuletmoInjectionAlready approved by the U.S. FDA and China NMPA for the prevention of cytomegalovirus (CMV) infection and cytomegalovirus disease in CMV-seropositive [R+] adult recipients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). In addition, the product was also approved by the U.S. FDA in 2023 for the prevention in high-risk individuals.Adult Kidney Transplant Recipients(Cytomegalovirus [CMV] disease in donor CMV positive/recipient CMV negative [D+/R-]).

The one declared for marketing this time isLetermovirMicrotablet formulation. Public information shows,Micro-tablets refer to miniature tablets with a diameter of no more than 4mm.It is a recommended small-dose formulation improvement plan suitable for children in the guidelines for pediatric drug development from the World Health Organization and China.

We look forward to the early availability of this Letemmovir microtablet for patients, offering more patients a new treatment option.

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Mar 8, 2025, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2] MSD’s Letermovir Injection (Prevymis®) Receives Approval from the China National Medical Products Administration for Prophylactic Treatment of Cytomegalovirus. Retrieved May 17， 2022, from https://mp.weixin.qq.com/s/2LAphBjiXhm9-ZHBUfqU_A

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