InflaRx announces Gohibic receives FDA Emergency Use Authorization

InflaRx N.V. announced that Gohibic, a first-in-class monoclonal anti-human complement factor C5a antibody, has been granted an Emergency Use Authorization by the U.S. Food and Drug Administration for the treatment of coronavirus disease 19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation, or ECMO. "InflaRx continues discussions with FDA related to submission of a BLA for full approval of Gohibic in this COVID-19 indication. InflaRx has also completed encouraging meetings with the rapporteur and co-rapporteur teams of the European Committee for Medicinal Products for Human Use, CHMP, related to a planned Marketing Authorization Application with the European Medicines Agency, or EMA. In addition, InflaRx is continuing to develop vilobelimab in other indications, including pyoderma gangrenosum, for which the Company is currently initiating a Phase III trial," the company stated.