FDA Grants Emergency Use Authorization for Vilobelimab in Treating Critically Ill COVID-19 Patients

Jena, Germany, April 04, 2023 – InflaRx N.V. announced that Gohibic (vilobelimab) has been granted an Emergency Use Authorization (EUA) by the FDA for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).

Prof. Niels C. Riedemann, CEO and Founder of InflaRx, expressed pride in the FDA's recognition of vilobelimab's lifesaving potential for critically ill COVID-19 patients. Despite available vaccines and treatments, many patients progress to critical status, necessitating invasive mechanical ventilation and resulting in high mortality rates.

The EUA was supported by data from the Phase III PANAMO trial, one of the largest randomized, double-blind, placebo-controlled trials in invasively mechanically ventilated COVID-19 patients. The trial involved 369 patients and showed a 23.9% relative reduction in 28-day all-cause mortality with vilobelimab treatment compared to placebo.

InflaRx is in discussions with the FDA for a Biologics License Application (BLA) for full approval of Gohibic for COVID-19 treatment and has engaged with the European Medicines Agency (EMA) for a Marketing Authorization Application. The company is also exploring vilobelimab's potential in other indications, including pyoderma gangrenosum.

Prof. Renfeng Guo, M.D., Chief Scientific Officer and Founder of InflaRx, highlighted the EUA as recognition of the company's COVID-19-related research and the potential of C5a inhibition in treating inflammatory diseases.

InflaRx has a supply of Gohibic available and is working to increase production to meet demand in the U.S. The company is assessing options for supplying the drug to hospitals and will provide more information as it becomes available.

Important safety information includes the risk of serious infections and hypersensitivity reactions. Healthcare providers are responsible for reporting all medication errors and serious adverse events or deaths potentially attributable to Gohibic.