The National Medical Products Administration (NMPA) of China has granted approval for Takeda’s antiviral agent Livtencity (maribavir) to treat adults with post-hematopoietic stem cell transplant or solid organ transplant cytomegalovirus (CMV) infection/disease.
The treatment is indicated for patients who are refractory to conventional anti-CMV treatment comprising ganciclovir, valganciclovir, cidofovir or foscarnet.
An oral, anti-CMV-specific compound, Livtencity acts on and hinders UL97 protein kinase.
The latest approval is based on data from the randomised, multicentre, international, open-label, active-controlled Phase III SOLSTICE clinical trial, which assessed the efficacy and safety of maribavir compared to standard antiviral treatments in 352 patients.
Livtencity was demonstrated to be superior to standard therapies at week eight for the primary endpoint of confirmed CMV viremia clearance in post-transplant adult patients with refractory CMV infection.
The antiviral agent is now approved in 12 countries and regions, including Canada, the US, Australia and the European Union, to treat post-transplant CMV infection refractory to prior therapies.
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In 2021, Livtencity received breakthrough therapy designation from the China Center for Drug Evaluation.
Takeda global portfolio division president Ramona Sequeira stated: “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.”
In November 2023, the US Food and Drug Administration approved the company’s Adzynma (recombinant-krhn ADAMTS13 ) to treat patients with congenital thrombotic thrombocytopenic purpura, a rare blood clotting disorder.
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