(RTTNews) - InflaRx N.V. (IFRX), a biopharmaceutical company specializing in anti-inflammatory therapeutics, announced on Wednesday that the European Commission or EC has granted marketing authorization for GOHIBIC or vilobelimab under exceptional circumstances.
The approval is for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome or ARDS who are receiving systemic corticosteroids as part of standard care and require invasive mechanical ventilation or IMV, with or without extracorporeal membrane oxygenation or ECMO.
GOHIBIC is the first and only approved treatment in the European Union for SARS-CoV-2-induced ARDS. The approval is based on positive results from the Phase 3 PANAMO trial, which demonstrated a 23.9% relative reduction in 28-day all-cause mortality compared to placebo.
This study was one of the largest trials of its kind and involved invasively mechanically ventilated COVID-19 patients in intensive care units.
The approval, which is valid in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway, provides an important therapeutic option in the critical care setting.
InflaRx is considering commercial partnerships and distribution options in the EU but does not expect this to significantly impact its cash burn rate.
Currently IFRX is trading at $2.49 up by 5.04%.
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