FDA approves Livtencity as first treatment for drug-resistant post-transplant infection
pharmafile | November 24, 2021 | News story | Manufacturing and Production, Research and Development |
The FDA have approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients with a common type of viral infection, with or without genetic mutations causing resistance, occurring in patients after organ transplant. The treatment prevents the activity of human cytomegalovirus enzyme pUL97, blocking virus replication. Livtencity will be used to treat patients with post-transplant cytomegalovirus (CMV) infection that does not respond to available antiviral treatment for CMV.
The infection is caused by a type of herpes virus called cytomegalovirus (CMV). CMV commonly causes infection in patients after stem cell or organ transplant, and can have a major negative impact on transplant recipients, including loss of the transplanted organ, as well as death. Livtencity received Breakthrough Therapy and Priority Review designations, and the FDA have approved Takeda’s drug for use against CMV among patients who do not respond to available antiviral treatments.
Livtencity’s safety and efficacy were evaluated in a Phase III, multicenter, open-label, active-controlled trial that compared Livtencity with a treatment assigned by a researcher running the study, which could include one or two antivirals used to treat CMV: ganciclovir, valganciclovir, foscarnet or cidofovir. The study compared the two groups’ plasma CMV DNA concentration levels at the end of the study’s eighth week. Of the 235 patients who received Livtencity, out of the 352 transplant recipients involved in the study, 56% had levels of CMV DNA below what was measurable, in comparison to 24% of the 117 patients in the study who received an investigator-assigned treatment.
“Transplant recipients are at a much greater risk for complications and death when faced with a cytomegalovirus infection,” said John Farlay, MD, MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern. Today’s approval helps meet a significant unmet medical need by providing a treatment option for this patient population.”
Ana Ovey
