FDA Advisory Recommends Approval of Takeda’s Maribavir

If approved, maribavir would be the first therapy to treat transplant patients with cytomegalovirus.

The FDA’s Antimicrobial Drugs Advisory Committee voted unanimously to recommend use of Takeda’s maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease in those who have a resistance ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients. The committee also voted unanimously to recommend use of maribavir for the treatment of refractory CMV infection and disease without genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients. Both recommendations were based on the results of the phase 2 and phase 3 trials.

A new drug application for maribavir is currently under priority review by the FDA.

“The vote in favor of our investigational antiviral drug marks a significant step towards delivering the first approved treatment for adult transplant recipients with refractory CMV infection and disease, with or without resistance,” Obi Umeh, M.D., vice president and maribavir global program leader at Takeda, said in a statement.

CMV is a common infection, but people with weakened immune systems can have more serious disease affecting the eyes, lungs, liver, esophagus, stomach, and intestines. Out of the estimated 200,000 adult transplants per year globally, CMV is one of the most common viral infections experienced by transplant recipients, with an estimated incidence rate between 16% to 56% in solid organ transplant recipients and 30% to 70% in stem cell transplant recipients, according to data supplied by Takeda.