Biopharmaceutical company InflaRx has launched Gohibic (vilobelimab) in the US for the treatment of Covid-19.
In April 2023, Gohibic was granted an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) in hospitalised adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).
Professor Niels Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “We are excited to make Gohibic available to certain critically ill Covid-19 patients in the US. Our team is proud to contribute to the fight against this terrible virus with a potentially lifesaving therapeutic option for some of the most critically ill Covid-19 patients.”
The data supporting the EUA were based on the previously announced results of the multicentre Phase III PANAMO trial, which showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set.
Gohibic is currently the only drug directed against the complement factor C5a that is authorised for the treatment of certain critically ill Covid-19 patients.
InflaRx has also completed encouraging meetings with the rapporteur and co-rapporteur member state teams of the European Committee for Medicinal Products for Human Use (CHMP) related to a planned Marketing Authorisation Application with the European Medicines Agency (EMA).