Takeda: FDA Panel Supports Maribavir To Treat Post-Transplant Recipients With CMV Infection& Disease

(RTTNews) - Takeda Pharmaceutical Company Limited (TAK) said that the U.S. Food and Drug Administration Antimicrobial Drugs Advisory Committee voted unanimously to recommend use of maribavir (TAK-620) for the treatment of refractory cytomegalovirus or CMV infection and disease with genotypic resistance to 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.

CMV is one of the most common infections experienced by transplant recipients, with an estimated incidence rate of around 16-56% in solid organ transplant (SOT) recipients and 30-70% in HSCT recipients.

The New Drug Application for maribavir is currently under Priority Review by the FDA. The FDA will consider the vote as part of its review of the NDA and is not bound by the committee's recommendation.