FDA offers support for Takeda's potential cytomegalovirus drug ahead of adcomm
After almost two decades of discussions with FDA regarding the development of Takeda’s potential drug for post-transplant cytomegalovirus (CMV), which it bought in its acquisition of Shire in 2019, the agency seems to be offering positive marks for the drug’s safety and efficacy profile ahead of Thursday’s adcomm.
According to FDA’s briefing documents released ahead of the meeting, maribavir proved safe across multiple studies and statistically superior to investigator-assigned treatment (IAT) in a Phase III trial, which Takeda announced earlier this year.
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