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news.Takeda has received approval from the Japanese Ministry of Health, Labour and Welfare for LIVTENCITY (maribavir) for the treatment of post-transplant cytomegalovirus (CMV) infections that are refractory to existing anti-CMV therapies.
According to the safety evaluation, 60.3% patients experienced adverse reactions related to the treatment. Credit: Herney Gómez from Pixabay.
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LIVTENCITY is the first and only treatment approved in the country targeting the pUL97 kinase.
The approval was based on the Phase III SOLSTICE trial results, which demonstrated the therapy’s efficacy and safety in comparison to alternative antiviral treatments.
The trial involved patients who underwent solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT).
At the end of week 8, maribavir showed a statistically significant improvement in the primary endpoint of confirmed CMV viremia clearance.
According to the safety evaluation, which included 234 patients, 60.3% experienced adverse reactions related to the treatment.
The therapy is administered orally and is distinguished by its unique action on the CMV-specific UL97 protein kinase.
As of this month, it has been approved in over 30 countries, including the US, Canada, Australia, the European Union, and China, for use in post-transplant patients with CMV infections refractory to previous therapies.
Takeda R&D Japan Region head Yasushi Kajii said: “A diagnosis of CMV infection can be particularly challenging for patients, and serious complications such as increased organ rejection and hospitalisation rates can occur, when not successfully treated.
“We believe LIVTENCITY has the potential to help address the challenges faced by people with post-transplant CMV and transform the treatment landscape for patients in Japan.”
The beta herpesvirus CMV commonly infects humans and typically resides latent and asymptomatic in the body. However, it may reactivate during immunosuppression.
