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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) 
  • 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  
  • The company is seeking commercial distribution partnerships in the EU for Gohibic (mAb targeting human complement factor C5a) 

Ref: InflaRx | Image: InflaRx | Press Release

Related News:- BMS’ Augtyro (Repotrectinib) Gains the CHMP’s Positive Opinion to Treat Advanced ROS1+ NSCLC and NTRK+ Solid Tumors

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