InflaRx gets EC’s approval for Gohibic for SARS-CoV-2-Induced ARDS

InflaRx N.V. announced Thursday that the European Commission (EC) has granted marketing authorization under exceptional circumstances for GOHIBIC^® (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) with or without extracorporeal membrane oxygenation (ECMO).

GOHIBIC is the first and only treatment approved in the European Union for the treatment of SARS-CoV-2-induced ARDS, InflaRx has noted.

Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, said that the European Commission’s approval of GOHIBIC, the first approval of its kind, reflects the company’s commitment to ICU patients with SARS-CoV-2-induced ARDS, a pressing medical setting in need of more effective therapeutic options.

The marketing authorization under exceptional circumstances for GOHIBIC is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway. InflaRx is considering commercial partnering and distribution options in the EU and does not expect this approach will have a meaningfully negative impact on its cash burn rate.