The European Commission (EC) has granted marketing authorisation under exceptional circumstances for InflaRx’s Gohibic (vilobelimab) for the treatment of SARS-CoV-2-induced acute respiratory distress syndrome (ARDS).
Patients with ARDS due to Covid-19 who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) with or without extracorporeal membrane oxygenation (ECMO) will be eligible for German biopharma’s therapy. InflaRx stated it is “considering commercial partnering and distribution options” in the EU.
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The EC’s exceptional circumstances pathway exists when gaining comprehensive data on a treatment is unlikely due to the rarity of the disease. The US Food and Drug Administration (FDA) chose a similar pathway for the drug, granting emergency use in April 2023. InflaRx stated it would provide annual updates to the European Medicines Agency (EMA) with results from a platform study being conducted by the US Biomedical Advanced Research and Development Authority (BARDA), in which Gohibic is one of three therapies being evaluated for ARDS.
The exceptional circumstances marketing authorisation does require a positive benefit/risk assessment, with Gohibic’s approval in the EU being supported by the Phase III PANAMO trial (NCT04333420). The results showed that treatment with InflaRx’s therapy improved survival – the all-cause mortality rate at 28 days was 32% in the Gohibic group and 42% in the placebo group. The trial enrolled 368 patients, with 177 receiving InflaRx’s therapy and 191 receiving placebo.
Although it leads to a lower mortality rate in Covid-19 patients with ARDS, Gohibic has been associated with an increase in serious infections. Hypersensitivity reactions have been observed in patients taking the treatment and the most common adverse reactions mostly include lung conditions and bacterial infections.
Gohibic is a monoclonal antibody that binds to and blocks the activity of the human complement factor C5a. This protein plays a key role in the initiation and maintenance of inflammatory pathways. ARDS is a serious condition that causes fluid to build up in the lungs and its onset can be triggered by infection with SARS-CoV-2.
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By GlobalDataWhile the World Health Organization (WHO) declared the Covid-19 pandemic over in May 2023, the SARS-CoV-2 virus is still in global circulation. Data from England’s National Health Service (NHS) in mid-2024 showed an uptick in Covid-19 infections and hospitalisations due to a group of mutations called FLiRT.
InflaRx’s CEO Niels C Riedemann said intensive care unit patients with SARS-CoV-2-induced ARDS is a “pressing medical setting in need of more effective therapeutic options”.
InflaRx’s pipeline also includes INF904, an oral C5aR inhibitor being evaluated in immune-dermatology indications. The company is testing vilobelimab in an indication beyond ARDS – pyoderma gangrenosum, an autoinflammatory disease that causes painful ulcers on the skin.
