InflaRx’s Gohibic (Vilobelimab) Receives the EC Approval for the Treatment of ARDS
Shots:
- The EC has approved (under exceptional circumstances) Gohibic to treat SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) adults on SoC (incl. systemic corticosteroids) & IMV (with/without ECMO)
- Approval was backed by results of the P-III (PANAMO) study assessing Gohibic vs. PBO among invasively mechanically ventilated COVID-19 patients in the ICU, which showed improvement in survival with a 23.9% relative reduction in 28-day all-cause mortality.
- The data was published in The Lancet Respiratory Medicine
- The marketing authorization for GOHIBIC is valid in all 27 EU member states, Iceland, Liechtenstein, and Norway. InflaRx is exploring commercial partnerships in the EU
Ref: InflaRx | Image: InflaRx
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