Current Report Articles
FDA Authorizes Gohibic (vilobelimab) Injection for the Treatment of COVID-19
FDALogo (April 7, 2023) – The Food and Drug Administration has granted emergency use authorization for the monoclonal antibody vilobelimab (Gohibic—InflaRx NV) for the treatment of hospitalized COVID-19 patients when administered within 48 hours of undergoing invasive mechanical ventilation or extracorporeal membrane oxygenation (artificial life support). The injection targets a portion of the immune system that is believed to have an effect on the inflammation that triggers disease progression in COVID-19 patients. A late-stage trial found that patients treated with vilobelimab had a reduced risk of death by day 28 and day 60 of treatment compared with a placebo. InflaRx is currently in talks with the FDA about applying for full approval for vilobelimab for this COVID-19 indication. According to the FDA, the recommended dosage is 800 mg administered through I.V. infusion after dilution, injected up to six times during the treatment period. Additional safety information, dosing instructions, and potential side effects can be found in the authorized Fact Sheet for Health Care Providers. Additional information on authorized COVID-19 treatments is available on FDA's Emergency Use Authorization webpage.
--Karen Braman