
FDA's antimicrobial adcomm unanimously backs Takeda's drug for post-transplant cytomegalovirus
The FDA’s antimicrobial drugs advisory committee on Thursday voted unanimously in favor of FDA approving Takeda’s antiviral for post-transplant cytomegalovirus.
The adcomm voted 17-0 on the question of whether the overall benefit-risk profile is favorable for the use of Takeda’s maribavir for the treatment of transplant recipients with CMV infection and disease refractory to treatment and with genotypic resistance to four other antivirals — ganciclovir, valganciclovir, foscarnet or cidofovir.
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