The European Commission has authorised GOHIBIC® (vilobelimab) from InflaRx in Planegg, Germany, for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS).
This approval applies to patients receiving systemic corticosteroids and undergoing invasive mechanical ventilation, with or without extracorporeal membrane oxygenation (ECMO). GOHIBIC® is therefore the first and only therapy authorised in the European Union for this indication.
The approval is based on the results of the multicentre Phase 3 PANAMO study, one of the largest randomised, double-blind, placebo-controlled studies on invasively ventilated COVID-19 patients in intensive care units. The results showed that treatment with vilobelimab improved survival and reduced 28-day all-cause mortality by 23.9% compared to placebo. These data were published in the journal ‘The Lancet Respiratory Medicine’.
Vilobelimab is a highly specific monoclonal antibody that selectively inhibits the complement protein C5. This protein plays a central role in the activation of the complement system, which contributes significantly to the excessive immune response often observed in severe COVID-19. By inhibiting C5, vilobelimab interrupts the inflammatory cycle without interfering with the formation of C5a-dependent membrane attack complexes. This ensures that important protective functions of the immune system are preserved while mitigating the harmful effects of the excessive immune response.
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “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."
The marketing authorisation for GOHIBIC® is valid in all 27 EU member states as well as in Iceland, Liechtenstein and Norway.