LIVTENCITY is a new molecular entity. It targets CMV at pUL97, resulting in inhibition of viral DNA replication, encapsidation and nuclear egress.
CMV is one of the most common infections experienced by transplant recipients, with an estimated incidence rate of around 16%–56% in solid organ transplant (SOT) recipients and 30%–70% in hematopoietic stem cell (HSCT) transplant patients.
CMV can be acquired or reactivated following transplant leading to serious consequences—including loss of the transplanted organ and failure of the graft or loss of life. In patients with compromised immunity, CMV causes clinically challenging complications that can be fatal.
In transplant recipients, reactivation of CMV can lead to serious consequences including loss of the transplanted organ and, in extreme cases, can be fatal. Existing therapies to treat post-transplant CMV infections may demonstrate serious side effects that require dose adjustments or may fail to adequately suppress viral replication.11,12,15,18,19 Additionally, existing therapies may require or prolong hospitalization due to administration.14
LIVTENCITY (maribavir) – an orally bioavailable anti-CMV compound, the first and only antiviral agent that inhibits the pUL97 protein kinase and its natural substrates. It is indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.
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Takeda Pharmaceutical Product LIVTENCITY Granted Approval by the FDA
Takeda Pharmaceutical Granted FDA Approval for LIVTENCITY for Post-Transplant Cytomegalovirus
On November 23, 2021 Takeda Pharmaceutical Co Ltd (TAK) announced that the U.S. FDA has approved LIVTENCITY™ (maribavir) for adults and pediatric patients (12 years of age or older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.
From Takeda Pharmaceutical Co Ltd
Ramona Sequeira, President, U.S. Business Unit and Global Portfolio Commercialization of Takeda Pharmaceutical Company Limited, said, “The announcement redefines the management of post-transplant Cytomegalovirus with the approval of the first and only treatment for transplant patients with CMV that is refractory with or without resistance, a significantly underserved and vulnerable patient community. People undergoing transplants have a lengthy and complex healthcare journey; with the approval of this treatment, we’re proud to offer these individuals a new oral antiviral to fight CMV infection and disease. We are grateful for the contributions of the patients and clinicians who participated in our clinical trials, as well as the dedication of our scientists and researchers.”