Takeda Pharmaceutical Company announced that the U.S. FDA's Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend the use of maribavir, an investigational antiviral drug designed to treat one of the most common infections experienced by transplant recipients.
Based on the results of Takeda's phase 2 and phase 3 SOLSTICE trials, the committee recommended the use of maribavir for the treatment of refractory cytomegalovirus (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.
Maribavir, an orally bioavailable anti-CMV compound, is the only antiviral agent presently in phase 3 development for the treatment of adult post-transplant patients with CMV in SOT or HSCT.
The New Drug Application for maribavir is currently under Priority Review by the FDA.
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