Takeda has received approval from the National Medical Products Administration (NMPA) of China for Livtencity (maribavir) to treat certain adult patients with post-transplant cytomegalovirus (CMV) refractory to prior therapies.
Livtencity is an orally bioavailable anti-CMV compound. It is the first and only antiviral agent that targets and stops the UL97 protein kinase and its natural substrates, said Takeda.
The drug has been approved by NMPA to treat adults with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) CMV infection/disease that is refractory to treatment with ganciclovir, valganciclovir, cidofovir or foscarnet.
Livtencity secured the Breakthrough Therapy Designation by China’s Center for Drug Evaluation (CDE) in 2021.
Takeda Global Portfolio Division president Ramona Sequeira said: “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.
“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.”
The authorisation was based on the findings from the global, multicentre, randomised, open-label, active-controlled superiority Phase 3 SOLSTICE trial.
It assessed the safety and efficacy of maribavir against traditional antiviral therapies in 352 patients.
The patients were randomised 2:1 to Livtencity or conventional antiviral therapies for up to eight weeks followed by a 12-week follow-up phase.
According to the results, the anti-CMV compound was found superior to conventional therapies at week eight, thus meeting the primary endpoint of confirmed CMV viremia clearance in post-transplant adults with refractory CMV infection.
With this approval, Livtencity has now received clearance for 12 countries globally, including the US, Canada, Australia, and the European Union.
In November 2021, Takeda secured the US Food and Drug Administration (FDA) approval for the drug to treat patients, aged 12 years and above, with post-transplant CMV disease.
