FDA has approved Takeda Pharmaceutical’s (NYSE:TAK) Livtencity (maribavir) for use in patients at least 12 years old with post-transplant cytomegalovirus (CMV) infection or disease that does not respond to available antiviral therapy. The indication covers patients weighing at least 35 kilograms.
Livtencity blocks virus replication by blocking the activity of the human cytomegalovirus enzyme pUL97.
According to data gathered by Takeda, the infection is present in 16–56% of solid organ transplants and 30–70% of hematopoietic stem cell transplants.
CMV infections cause an increased risk of complications and death for transplant recipients, said Dr. John Farley, 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,” Farley said in a press release. “Today’s approval helps meet a significant unmet medical need by providing a treatment option for this patient population.”
To win the approval, Takeda shared data from a Phase 3 trial that administered Livtencity to patients who did not respond to two CMV antivirals, including ganciclovir, valganciclovir, foscarnet or cidofovir.
Before approval, FDA granted the drug Orphan Drug Designation and Breakthrough Therapy Designation.