A new treatment for acute respiratory distress syndrome (ARDS) received a positive opinion from the European Medicines Agency on 15 November paving the way for its use in patients with a coronavirus infection. The treatment, Gohibic (vilobelimab), is a monoclonal antibody directed against a component of the complement system which is part of the body’s immune system. By targeting the complement component C5a, the antibody is believed to block an inflammatory response induced by severe SARS-CoV-2 infection. The treatment has been developed by InflaRx NV of Germany.
The positive opinion was issued under a provision known as ‘exceptional circumstances’ which means the company will be required to provide annual updates to the EMA on a platform study of Gohibic and two other drugs which is being undertaken by the US Biomedical Advanced Research and Development Authority. The opinion is based on the results of a Phase 3 study showing that treatment with vilobelimab of Covid-19 hospitalised patients improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared with a placebo.
The opinion will be followed by a decision on marketing authorisation by the European Commission. In 2023, InflaRx received an emergency use authorisation for vilobelimab from the US Food and Drug Administration. It has not been formally approved by the FDA. According to InflaRx, vilobelimab blocks the biological activity of C5a, leaving the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system.
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