Takeda has announced the approval of LIVTENCITY® (maribavir) by the National Medical Products Administration (NMPA) of China for treating adults with post-transplant cytomegalovirus (CMV) infections that are refractory to standard anti-CMV treatments, including ganciclovir, valganciclovir, cidofovir, or foscarnet. LIVTENCITY, which inhibits the CMV-specific UL97 protein kinase, is the first approved in China for this patient population.
CMV poses a significant threat to transplant recipients, potentially leading to serious complications such as increased organ rejection and higher hospitalization rates. Ramona Sequeira, President of Takeda’s Global Portfolio Division, emphasized the importance of this approval for transplant care, stating that it will help transform the treatment landscape for these patients in China.
The NMPA’s decision was influenced by the Phase 3 SOLSTICE trial, which found LIVTENCITY more effective than conventional therapies in clearing CMV viremia within eight weeks of treatment. This approval in China follows previous approvals in other major markets, including the United States, Canada, Australia, and the European Union, making it the 12th global approval for LIVTENCITY.
CMV is a common issue among the estimated 200,000 adult transplants conducted globally each year, with considerable percentages of SOT and HSCT recipients experiencing infections. LIVTENCITY is specifically engineered to target and inhibit the UL97 protein kinase, impacting its natural substrates, providing a novel treatment option for this serious condition in the post-transplant setting.
Source link: http://www.businesswire.com/news/home/20231221976317/en/Takeda-Announces-China-NMPA-Approval-of-LIVTENCITY%C2%AE-maribavir-for-the-Treatment-of-Adults-With-Post-transplant-Cytomegalovirus-CMV-Refractory-to-Prior-Therapies