InflaRx secures European Commission approval for ARDS drug

GOHIBIC (Vilobelimab) becomes the first and only approved treatment in the European Union for SARS-CoV-2-induced ARDS, a condition with high mortality and limited therapeutic options. The European Commission has granted marketing authorization under exceptional circumstances – for the treatment of adult patients suffering from SARS-CoV-2-induced ARDS who are undergoing invasive mechanical ventilation (IMV), with or without extracorporeal membrane oxygenation (ECMO), and are already receiving systemic corticosteroids as part of standard care. The approval is valid in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.

“The European Commission’s approval of GOHIBIC, the first approval of its kind, reflects our commitment to Intensive Care Unit patients with SARS-CoV-2-induced ARDS, a pressing medical setting in need of more effective therapeutic options”, said Niels C. Riedemann, CEO and Founder of InflaRx N.V.

Founded in 2007, the Jena-based biopharmaceutical company is a pioneer in developing anti-inflammatory therapeutics targeting the complement system. Vilobelimab, its first-in-class monoclonal antibody, targets human complement factor C5a. Pre-clinical studies have demonstrated its ability to control the inflammatory response-driven tissue and organ damage by specifically blocking C5a as a key amplifier of this response. The multicenter Phase 3 PANAMO trial results showed that vilobelimab treatment improved survival of invasively mechanically ventilated COVID-19 patients with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set. Furthermore, Vilobelimab is currently in clinical development for treatment of pyoderma gangrenosum (PG).

A marketing authorisation under exceptional circumstances is granted when the benefit-risk balance is considered positive, but due to the rarity or complexity of the disease, gathering comprehensive data under standard conditions is unlikely. In the United States, GOHIBIC has already been authorised for emergency use by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalised adults, provided treatment begins within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).