InflaRx’s Gohibic (Vilobelimab) Gains the CHMP’s Positive Opinion for the Treatment of ARDS
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The CHMP has recommended Gohibic (under exceptional circumstances) to treat SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) adults on systemic corticosteroids (SoC) & IMV (with/without ECMO), with the decision anticipated within 67days (Q1’24)
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Opinion was backed by P-III (PANAMO) study of Gohibic vs PBO among invasively mechanically ventilated COVID-19 patients in ICU, showing improvement in survival with a 23.9% relative reduction in 28-day all-cause mortality. Data was published in The Lancet Respiratory Medicine
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The company is seeking commercial distribution partnerships in the EU for Gohibic (mAb targeting human complement factor C5a)
Ref: Inflarx | Image: Inflarx
Related News:- InflaRx Receives the US FDA’s EUA for Gohibic (vilobelimab) to Treat COVID-19
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com