FDA Authorizes InflaRx’s Gohibic for Severe Forms of COVID-19

The FDA has granted Emergency Use Authorization (EUA) to InflaRx’s Gohibic (vilobelimab) to treat COVID-19 in adults who are hospitalized.

The monoclonal antibody is authorized for administration within 48 hours of patients receiving invasive mechanical ventilation or extracorporeal oxygenation.

The agency decision was supported by results from a phase 3 clinical trial, which showed that the Gohibic treatment led to improved survival, with a 23.9 percent relative reduction in 28-day all-cause mortality compared to placebo.

The company is in discussions with the FDA about a related biologics license application (BLA) seeking full regulatory approval of Gohibic and plans to submit a marketing authorization application to the European Medicines Agency (EMA).

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