Takeda’s Livtencity Bags FDA Approval for the Treatment of Post-Transplant Infection

On November 24th, the FDA approved Takeda’s Livtencity (maribavir) for patients with post-transplant cytomegalovirus (CMV) infection, a common complication that is tricky to treat owing to drug resistance. Prior to the approval, the drug had received Orphan Drug Designation from the FDA.

The treatment will be accessible to patients aged 12 and older with a weight of at least 35 kg who have not responded well to existing antiviral treatments such as ganciclovir and valganciclovir.

“Transplant recipients are at a much greater risk for complications and death when faced with a cytomegalovirus infection,” said 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. Today’s approval helps meet a significant unmet medical need by providing a treatment option for this patient population.”

A Common and Deadly Infection

CMV, a type of herpes virus, is one of the most common viral infections to affect transplant recipients. Around 16%-56% of solid organ transplant recipients and 30%-70% hematopoietic stem cell recipients get infected. 

While CMV is usually dormant in the body, immunosuppression during transplant surgery may reactivate it. Reactivation could cause loss of the transplanted organ or even death.

Livtencity Blocks CMV Replication 

Livtencity blocks viral replication via first-in-class inhibition of human CMV enzyme pUL97. 

The US approval is based on results from the SOLSTICE study, which involved 352 transplant patients with treatment-resistant infection. The Phase 3 trial showed that Livtencity was superior to standard treatments ganciclovir, valganciclovir, foscarnet, and cidofovir. 56% of the 235 patients who received Livtencity had CMV DNA levels below what was measurable, compared to 24% of 117 patients who received one of the assigned antivirals.

The drug is also being investigated in a Phase 3 trial as a first-line treatment of CMV in hematopoietic stem cell transplantation. 

Common side effects of Livtencity included taste disturbance, nausea, diarrhea, vomiting, and fatigue. The drug could antagonize the effects of ganciclovir and valganciclovir, so it is not recommended to use the drugs together. Relapse of CMV could still occur, usually within 4-8 weeks after treatment discontinuation.

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Joy Lin

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