Vilobelimab

In the US, vilobelimab is authorized via an emergency use authorization for use in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (artificial life support). Vilobelimab is not approved by the US Food and Drug Administration (FDA) for any indication, including for the treatment of COVID-19. In the EU, vilobelimab is indicated for the treatment of adults with SARS-CoV-2 induced acute respiratory distress syndrome who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (with or without extracorporeal membrane oxygenation). == History ==

The clinical trial supporting the authorization showed that participants treated with vilobelimab had a lower risk of death by day 28 and day 60 of treatment compared to placebo. == Society and culture ==

Legal status In November 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization under exceptional circumstances for the medicinal product Gohibic intended for the treatment of adults with SARS‑CoV2‑induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids. Vilobelimab was authorized for medical use in the European Union in January 2025. == References ==