Monoclonal Antibody for COVID Gets FDA Emergency Use Authorization

(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.

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.

Source: MEDspace