The European Commission (EC) has granted marketing authorization under exceptional circumstances for InflaRx’s 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.
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, said: “The European Commission’s approval of GOHIBIC, the first approval of its kind, reflects our commitment to ICU patients with SARS-CoV-2-induced ARDS, a pressing medical setting in need of more effective therapeutic options.
“I would like to thank the entire InflaRx team for its dedication and diligence resulting in this successful marketing authorization, and we are grateful for the support provided by the intensive care physicians, patients and their families who participated in the PANAMO study which supported the marketing authorization application.”
The marketing authorization under exceptional circumstances for GOHIBIC is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway.
