Takeda’s Livtencity (maribavir) has been approved in China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease.
It has been licensed by the National Medical Products Administration (NMPA) in cases where the infection is resistant to treatment with ganciclovir, valganciclovir, cidofovir or foscarnet.
CMV is one of the most common infections experienced by transplant patients, with an estimated incidence rate of 16%-56% in SOT and 30%-80% in HSCT recipients.
“The approval of Livtencity by the NMPA of China recognises the critical need for post-transplant care and that CMV infection, when not successfully treated, can pose serious challenges to transplant recipients that can lead to complications such as increased organ rejection and hospitalisation rates,” said Ramona Sequeira, President, Global Portfolio Division, Takeda.
“This approval will help redefine the CMV treatment landscape for transplant patients in China and is a positive step forward toward addressing an unmet need for this community.”
Phase III SOLSTICE trial and previous approvals
The NMPA approval is based on the results of the Phase III SOLSTICE trial, which evaluated the safety and efficacy of maribavir versus conventional antiviral therapies for the treatment of patients with CMV infection/disease refractory to prior therapies.
In the SOLSTICE trial, Livtencity was superior to conventional therapies at week eight for the primary endpoint of confirmed CMV viremia clearancea in post-transplant adults with refractory CMV infection.
Livtencity is already approved for post-transplant CMV refractory to prior therapies in twelve other territories including the United States, Canada, Australia and the European Union.