New COVID-19 Monoclonal Antibody Authorized

InflaRx N.V. recently announced that Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, has been granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation, or extracorporeal membrane oxygenation.

The FDA issued EUA #118 on April 14, 2023.

InflaRx has a supply of Gohibic available and is working to ramp up production at its third-party manufacturer to roll out supply in the U.S. as soon as possible.

In a related press release, Prof. Niels C. Riedemann, CEO and Founder of InflaRx, said, "We are thrilled and very proud that the FDA has issued a EUA for vilobelimab to treat this very sick patient group, recognizing the lifesaving potential of this first-in-class drug."

According to the U.S. National Institutes of Health (NIH), monoclonal antibody (mAbs) products that target the SARS-CoV-2 coronavirus spike protein have been shown to have clinical benefits in limiting and treating infections that cause COVID-19. mAbs treatments block SARS-CoV-2 from entering cells in the human body.