Biopharmaceutical company InflaRx NV’s monoclonal antibody has been granted emergency use authorization (EUA) by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults.
The FDA said on April 4 that it had issued the EUA for the use of Gohibic, a brand name of vilobelimab, a monoclonal anti-human complement factor C5a antibody, to be injected into hospitalized adults when initiated within 48 hours of them receiving artificial life support.
InflaRx said the EUA was granted based on the results of the multicenter phase 3 “PANAMO trial,” which it said is one of the largest 1:1 randomized, double-blind placebo-controlled trials investigating treatments for invasively mechanically ventilated patients with COVID-19 who are hospitalized in intensive care units (ICU)….