FDA Approves First Treatment for Post-Transplant Cytomegalovirus

The US Food and Drug Administration (FDA) has approved maribavir (livtencity) as the first treatment for post-transplant cytomegalovirus infection/disease that does not respond to available antiviral treatment.

Maribavir is indicated for adults and children aged 12 years or older weighing at least 35 kg. The most common adverse effects reported in clinical trials include taste disturbance, nausea, diarrhea, vomiting, and fatigue. Maribavir should not be coadministered with ganciclovir and valganciclovir, as it may reduce the antiviral activity.

“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 press release. “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.”

—Amanda Balbi

Reference

FDA Approves First Treatment for Common Type of Post-Transplant Infection that is Resistant to Other Drugs. News Release. US Food and Drug Administration; November 23, 2021. Accessed December 2, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-common-type-post-transplant-infection-resistant-other-drugs