Infection with pathogenic filoviruses, such as Zaire ebolavirus (Ebola virus, EBOV), can cause severe hemorrhagic fever in humans, resulting in frequent outbreaks with case fatality rates as high as 90%.[A225933, A225938] Virtually all steps of the EBOV lifecycle have been targeted for therapeutic development. However, to date, the most successful method appears to be the development of monoclonal antibodies (mAbs) against the GP1,2 surface glycoprotein, as evidenced by the previously approved INMAZEB™ (REGN-EB3, a cocktail of [atoltivimab], [odesivimab], and [maftivimab]), the now approved ansuvimab, and ZMapp, which remains in clinical trials.[A225933] Ansuvimab, formerly mAb114, is a fully human IgG1 mAb derived from a survivor of the 1995 Kikwit EBOV outbreak 11 years after infection, which displays strong glycan-independent binding to a conserved region of the GP1,2 protein that is responsible for interacting with the host NPC1 protein to mediate EBOV endolysosomal escape, a key step in the EBOV lifecycle.[A225943, A225948, A226035] A randomized, controlled trial of four investigational therapies for Ebola virus disease (EVD) in the Democratic Republic of Congo during a previous outbreak that began in 2018 compared ansuvimab, REGN-EB3, ZMapp, and [remdesivir], a nucleoside analogue designed to inhibit viral replication, showed ansuvimab and REGN-EB3 to be superior, with improved patient survival and faster viral clearance rates.[A207646]
Ansuvimab received FDA approval on December 21, 2020, and is currently marketed as Ebanga by Ridgeback Biotherapeutics, LP. Ansuvimab is just the second FDA-approved treatment for EVD.[L29560]
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
Ansuvimab is the active ingredient of these drugs:
United States