Category: Approval/Launch Region: Europe · Germany Company: Inflarx Gmbh

InflaRx Announces FDA Emergency Use Authorisation for Gohibic (vilobelimab)

InflaRx Announces FDA Emergency Use Authorisation for Gohibic (vilobelimab)
InflaRx announced that Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, has been granted an Emergency Use Authorisation (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of coronavirus disease 19 (COVID-19) in hospitalised adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO). Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody that has been granted an EUA for the treatment of COVID-19 in hospitalised adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO). Vilobelimab is the first authorised drug to control complement factor C5a, a protein that plays an important and often harmful role in the body

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