EMA — authorised 13 January 2025
- Application: EMEA/H/C/006123
- Marketing authorisation holder: InflaRx GmbH
- Local brand name: Gohibic
- Indication: Gohibic is indicated for the treatment of adult patients with SARS-CoV2-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)).
- Pathway: exceptional circumstances
- Status: approved
On 13 January 2025, the European Medicines Agency (EMA) granted marketing authorisation for Gohibic (IFX-1), a treatment for adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS). This condition is characterised by severe lung inflammation and is often life-threatening. Gohibic is indicated for patients who are receiving systemic corticosteroids as part of standard care and are on invasive mechanical ventilation, with or without extracorporeal membrane oxygenation (ECMO).