(Reuters) – The U.S. Food and Drug Administration (FDA) on Tuesday granted emergency-use authorization to Inflarx NV’s monoclonal antibody for the treatment of hospitalized COVID patients when initiated within 48 hours of receiving artificial life support.
U.S.-listed shares of the German biopharmaceutical company rose almost 25% to $4.70 after the bell.
The injection known as Gohibic targets a part of the immune system that is thought to play a role in the inflammation that leads to COVID-19 disease progression.
The data supporting the authorization is based on a late-stage trial which showed that patients treated with Gohibic had a lower risk of death by day 28 and day 60 of treatment compared with a placebo.
Germany-based InflaRx is continuing discussions with the FDA related to the submission of an application for full approval of Gohibic in this COVID-19 indication.
The recommended dosage of Gohibic is 800 mg administered by intravenous infusion after dilution, given up to six times over the treatment period, the FDA said in a statement.
(Reporting by Sriparna Roy in Bengaluru; Editing by Devika Syamnath)
