Positive CHMP opinion for Gohibic (vilobelimab) for the treatment of SARS-CoV-2-induced acute respiratory distress syndrome
InflaRx N.V., a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization of GOHIBIC (vilobelimab), under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO))
The Company expects the European Commission to adopt the positive opinion and issue a marketing authorization within 67 days.
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “The positive CHMP opinion reflects a significant milestone in the development of our anti-C5a antibody vilobelimab, and, together with the previously received Emergency Use Authorization granted by the FDA, further validates its therapeutic potential. Patients in the ICU continue to die from SARS-CoV-2-induced ARDS, an important reminder of the ongoing need for more effective treatments for these patients. We are grateful to the intensive care physicians and patients’ families who worked with InflaRx on the PANAMO study.”
A marketing authorization under exceptional circumstances is recommended when the benefit/risk assessment is determined to be positive but, due to the rarity of the disease, it’s unlikely that comprehensive data can be obtained under normal conditions of use. Under the terms of Gohibic’s approval in the EU, which is anticipated early next year, InflaRx will provide annual updates to EMA on the previously announced clinical platform study planned by the Biomedical Advanced Research and Development Authority (BARDA). Vilobelimab is included in this study as one of three new potential therapies for treating ARDS.
InflaRx plans to commercialize the product in Europe under its proprietary brand name Gohibic. As previously indicated, InflaRx is considering commercial distribution options with potential partners in the EU. InflaRx does not expect this approach will have a meaningfully negative impact on its cash burn rate.
The positive CHMP opinion is supported by the previously announced results of the multicenter Phase III PANAMO trial, one of the largest 1:1 randomized, double-blind, placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units. The results showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set. The data were published in The Lancet Respiratory Medicine.
Citation: The Lancet Respiratory Medicine; Volume 10, Issue 12p1137-1146 December 2022 "Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase III trial". Prof Alexander P J Vlaar, MDl ∙ Prof Martin Witzenrath, MD ∙ Pieter van Paassen, MD ∙ Prof Leo M A Heunks, MD ∙ Prof Bruno Mourvillier, MD ∙ Sanne de Bruin, MD∙ et al.
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