InflaRx's Gohibic Approved for COVID-19 ARDS

InflaRx has received marketing authorization from the European Commission for its drug Gohibic (vilobelimab) to treat SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) in adults under exceptional circumstances. This approval makes Gohibic the first and only treatment authorized in the EU for this condition, based on positive results from the Phase III PANAMO trial, which demonstrated improved survival rates. The drug is specifically for patients receiving systemic corticosteroids and requiring invasive mechanical ventilation. InflaRx is exploring commercial partnerships for distribution in the EU but anticipates no significant impact on its cash flow. The approval is valid in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. While Gohibic has shown a reduction in mortality rates, it is associated with an increased risk of serious infections and hypersensitivity reactions.