InflaRx GmbH | MedPath

InflaRx's Gohibic (vilobelimab) Receives European Commission Approval for SARS-CoV-2-Induced ARDS

4 months ago

• InflaRx's Gohibic (vilobelimab) has been granted marketing authorization in the EU for treating SARS-CoV-2-induced acute respiratory distress syndrome (ARDS). • This approval makes Gohibic the first and only treatment approved in the European Union for this specific condition, addressing a critical unmet need. • The approval is based on Phase 3 PANAMO trial results, demonstrating a 23.9% relative reduction in 28-day all-cause mortality compared to placebo. • Gohibic is intended for adult patients receiving systemic corticosteroids and invasive mechanical ventilation, with or without extracorporeal membrane oxygenation.

InflaRx's Vilobelimab Receives Positive CHMP Opinion for COVID-19-Induced ARDS

6 months ago

• InflaRx received a positive CHMP opinion recommending marketing authorization for vilobelimab (GOHIBIC®) to treat SARS-CoV-2-induced ARDS in adults. • The recommendation is based on Phase 3 PANAMO trial results, which showed a 23.9% relative reduction in 28-day all-cause mortality compared to placebo. • Vilobelimab is intended for patients receiving systemic corticosteroids and invasive mechanical ventilation, addressing a critical need in severe COVID-19 cases. • InflaRx plans to commercialize GOHIBIC® in Europe and is exploring distribution partnerships, with minimal impact expected on the company's cash flow.

InflaRx's GOHIBIC (Vilobelimab) Selected for First BARDA-Sponsored Clinical Trial

a year ago

InflaRx N.V. announced that its drug GOHIBIC (vilobelimab) has been chosen by BARDA for a Phase 2 clinical trial to explore new treatments for acute respiratory distress syndrome (ARDS), a life-threatening lung condition with no currently approved therapy.