The FDA approved maribavir (Livtencity), the first drug indicated to treat patients with post-transplant cytomegalovirus (CMV) infection that doesn’t respond to available antiviral treatments.
CMV, a herpes subtype that often leads to infection in patients following stem cell or organ transplant, can “have a major negative impact on transplant recipients, including loss of the transplanted organ and death,” the FDA explained. The new drug, which is indicated for patients 12 years and older who weigh at least 35 kg, works by preventing the activity of human cytomegalovirus enzyme pUL97 to stop viral replication.
“Transplant recipients are at a much greater risk for complications and death when faced with a cytomegalovirus infection,” said John Farley, MD, MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement. “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.”
This approval was based on results from a phase III, multicenter, open-label, active-controlled trial that pitted maribavir against common CMV treatments, including ganciclovir, valganciclovir, foscarnet, or cidofovir—alone or in combination—for up to eight weeks in a cohort of 352 patients with CMV infection who did not respond (with or without resistance) to previous treatment.
“The study compared the two groups’ plasma CMV DNA concentration levels at the end of the study’s eighth week, with efficacy defined as having a level below what is measurable,” the FDA explained. “Of the 235 patients who received [maribavir], 56% had levels of CMV DNA below what was measurable versus 24% of the 117 patients who received an investigator-assigned treatment.”
Common side effects of maribavir included taste disturbance, nausea, diarrhea, vomiting, and fatigue. The agency also warned that maribavir can reduce the antiviral activity of ganciclovir and valganciclovir and thus should not be co-administered with either drug.
“Virologic failure due to resistance can occur during and after treatment with [maribavir],” the FDA noted, “therefore CMV DNA levels should be monitored and [maribavir] resistance should be checked if the patient is not responding to treatment or relapses.”
Maribavir is manufactured by Takeda Pharmaceuticals Company Limited.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 190
Topic ID: 79,190,730,190,138,192,725,925