FDA AdCom backs maribavir in CMV infection

The US Food and Drug Administration’s Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease with genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients, said Japan’s largest drugmaker, Takeda Pharmaceutical (TYO: 4502).

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 II and Phase III TAK-620-303 (SOLSTICE) trials.

“Today’s 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,” said Dr Obi Umeh, vice president and maribavir global program leader at Takeda. “We look forward to working with the FDA as it completes its review of our application.”