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April 5, 2023April 4, 2023 – InflaRx N.V. has announced that Gohibic (vilobelimab), a first-in-class monoclonal anti- human complement factor C5a antibody, has been granted an Emergency Use Authorization (EUA) by the FDA for the treatment of coronavirus disease 19 (COVID-19) in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO). InflaRx continues discussions with FDA related to submission of a BLA for full approval of Gohibic in this COVID-19 indication.
InflaRx has a supply of Gohibic (vilobelimab) available and is working to ramp up production at its third- party manufacturer to roll out supply in the U.S. as soon as possible. The Company is assessing all options for supplying drug to hospitals to enable the treatment of patients.