InflaRx COVID injection gets US FDA's emergency-use authorization (updated)

Inflarx NV

04/04/2023 21:14

(Adds details)
       April 4 (Reuters) - The U.S. Food and Drug
Administration (FDA) on Tuesday granted emergency-use
authorization to Inflarx NV's  IF0G.F  monoclonal antibody for
the treatment of hospitalized COVID patients when initiated
within 48 hours of receiving artificial life support.
    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)
 ((Sriparna.Roy@thomsonreuters.com;))