Takeda's Novel Antiviral Therapy Maribavir Approved in China for Refractory Cytomegalovirus Infections Post-Transplant

According to a report by PR Newswire on December 21, Takeda China's innovative antiviral drug Maribavir (Ityz®) has officially received NMPA approval. It is indicated for the treatment of cytomegalovirus (CMV) infection and/or disease in adult patients after hematopoietic stem cell transplantation or solid organ transplantation who are refractory to one or more prior treatments (ganciclovir, valganciclovir, cidofovir, or foscarnet), with or without genotypic resistance.

Image Source: PR Newswire Official Website

It is reported that maribavir is the world's first and currently the only antiviral agent that targets and inhibits the UL97 protein kinase and its natural substrates. Its approval will provide a new oral treatment option for transplant recipients in China suffering from refractory CMV infections or diseases.

Cytomegalovirus (CMV) is a β-herpesvirus capable of infecting humans and is one of the common infections in transplant patients. The incidence of cytomegalovirus (CMV) in solid organ transplant patients is approximately 16-56%, while in hematopoietic stem cell transplant patients, it is about 30-70%. In immunocompetent individuals, infection with cytomegalovirus (CMV) typically presents as short-term fever or is asymptomatic. Afterward, cytomegalovirus (CMV) remains latent for life in various cells, serving as a reservoir for reactivation, and carriers become susceptible populations. This virus not only increases the risk of illness in patients undergoing transplantation but may also elevate the risks of transplant rejection and opportunistic co-infections.

Maribavir is a UL97 protein kinase inhibitor that blocks viral replication by inhibiting the pUL97 protein kinase of cytomegalovirus (CMV). It is the first oral therapy for this patient population and offers higher safety compared to existing treatments.

Maribavir was granted Breakthrough Therapy Designation and Priority Review by the U.S. FDA. In November 2021, maribavir was approved for the first time by the U.S. FDA; in November 2022, the drug also received approval from the European Commission (EC). In January 2021, maribavir tablets were officially designated as a "Breakthrough Therapy Drug" by the CDE.

Source of the image: CDE official website

According to reports, in a multicenter, randomized, open-label, positive drug-controlled Phase III superiority study (TAK-620-303), the results showed that 55.7% (n=131/235) of patients treated with Maribavir tablets achieved clearance of CMV viremia by Week 8 (i.e., based on central laboratory results, the plasma CMV DNA concentration of two consecutive post-baseline samples, taken at least 5 days apart, was below the lower limit of quantification). In contrast, 23.9% (n=28/117) of patients receiving conventional treatment achieved the same result (adjusted difference [95% Confidence Interval (CI)]: 32.8% [22.80–42.74]; P<0.001).

At the same time, compared with conventional antiviral therapy, maribavir tablets have lower treatment-related toxicity. Research results show that 25% (n=14/56) of patients treated with valganciclovir/ganciclovir experienced treatment-related neutropenia, while only 1.7% (n=4/234) of patients treated with maribavir experienced this. At the same time, 19.1% (n=9/47) of patients treated with foscarnet sodium experienced acute kidney injury, while only 1.7% (n=4/234) of patients treated with maribavir experienced this.

Editor: Mu Mian

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