Livtencity is an orally bioavailable anti-CMV compound that works by blocking the activity of the human cytomegalovirus enzyme pUL97 to prevent the replication of viral DNA
Japanese pharmaceutical firm Takeda has received the US Food and Drug Administration (FDA) approval for Livtencity (maribavir) to treat a type of cytomegalovirus (CMV) infection.
The drug was indicated for patients with post-transplant CMV disease, aged 12 years and above, unresponsive to available antiviral treatment, regardless of genotypic resistance.
It is an orally bioavailable anti-CMV compound that works by blocking the activity of the human cytomegalovirus enzyme pUL97 to prevent the replication of viral DNA.
According to Takeda, Livtencity is the first and only antiviral agent that targets pUL97 protein kinase and its natural substrates.
The drug is being evaluated as a first-line treatment of CMV in hematopoietic stem cell transplant recipients in an ongoing Phase 3 clinical trial.
The regulatory approval for Livtencity in the US follows the orphan drug designation and breakthrough therapy designation from the FDA to treat CMV disease.
Takeda US business unit and global portfolio commercialisation president Ramona Sequeira said: “Today’s announcement redefines the management of post-transplant CMV 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.”
CMV is a type of herpes virus that predominantly infects patients who undergo transplantation procedures.
The infection may lead to CMV disease, which poses a negative impact on transplant recipients, including loss of the transplanted organ and death.
Livtencity was evaluated in SOLSTICE, a global, multicentre, randomised, open-label, active-controlled Phase 3 trial, in 352 transplant recipients with CMV infections.
The Phase 3 study has assessed the safety and efficacy of the drug, compared to investigator-assigned treatment (IAT), for eight weeks.
IAT comprises one or two antivirals including ganciclovir, valganciclovir, foscarnet or cidofovir.
A total of 235 patients received Livtencity, of which 56% showed reduced levels of CMV DNA compared to 24% of the 117 patients who received an IAT.
The primary endpoint of the Phase 3 study was achieving reduced levels of CMV DNA compared to the lower limit of quantification (LLOQ) in two consecutive samples, five days apart.
Reduced levels of CMV DNA level than LLOQ and CMV infection symptom control at the end of the eighth week was the key secondary endpoint.
Takeda said that it will continue its talks with global regulatory authorities to ensure approval and commercialisation of its CMV drug worldwide.