Takeda Pharmaceutical's orphan drug, Livtencity (ingredient: maribavir), received approval from the Ministry of Food Drug Safety (MFDS) on Tuesday to treat post-transplant cytomegalovirus.
Cytomegalovirus (CMV) is a common virus that stays in the human body for life once the person becomes infected. After infection, the virus can be reactivated and cause serious diseases when the immune system is compromised due to organ transplantation as the virus is asymptomatic in the latent state.
Livtencity is an oral antiviral drug that inhibits the growth of the virus by lowering the activity of the pUL97 protein kinase and its natural substrates which are involved in the cloning and proliferation of the CMV.
It was earlier approved this year in late November by the FDA. This announcement came after proving that more than twice the proportion of adult transplant patients with refractory or resistant (R/R) CMV infection confirmed a lower CMV DNA level than the lower limit of quantitation (LLOQ) at Week 8 with Livtencity compared to those treated with conventional antiviral therapies in phase 3 clinical studies.
The drug is expected to provide new treatment opportunities for adult patients with macrophage virus infection after transplantation, which is resistant or unresponsive to one or more of the existing antiviral drugs ganciclovir, valganciclovir, foscarnet, and cidofovir.
According to Takeda, CMV is one of the most common and serious post-transplant infections with an estimated incidence rate of around 16 to 56 percent in solid organ transplant recipients and 30 to 70 percent in hematopoietic stem cell transplant recipients.
“People undergoing transplants have a lengthy and complex healthcare journey,” said Takeda Pharmaceutical's President of Global Portfolio Commercialization, Ramona Sequeira. “We are proud to provide the first and only treatment for transplant patients with CMV that is refractory with or without resistance, a significantly underserved and vulnerable patient community.”
An MFDS official said they will continue to do their best to expand treatment opportunities for patients with rare and incurable diseases by quickly supplying treatments that have been sufficiently verified for safety and effectiveness.