Japanese pharmaceutical company Takeda (TYO: 4502) has received its first market approval from China’s National Medical Products Administration (NMPA) for Livtencity (maribavir), a significant milestone for the treatment of adult patients with cytomegalovirus (CMV) infection/disease following hematopoietic stem cell transplantation or solid organ transplantation. The drug is particularly indicated for patients who have difficulty using other therapies, including those with genotype resistance to ganciclovir, valganciclovir, cidofovir, or foscarnet.
Maribavir is an innovative oral anti-CMV drug that targets the CMV UL97 protein kinase, offering a triple inhibition of replication, capsid formation, and nuclear egress of viral DNA, which helps in clearing CMV-associated anemia and controlling related symptoms. As the world’s first and only anti-viral preparation inhibiting the UL97 protein kinase, maribavir was granted breakthrough therapy designation (BTD) in China in January 2021. Takeda has previously obtained market approvals for maribavir in the US in November 2021 and in the European Union in November 2022.- Fineline.com