InflaRx announced the commercial launch of Gohibic (vilobelimab) in the US In April 2023, Gohibic was 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, Chief Executive Officer and Founder of InflaRx, commented: “We are excited to make Gohibic available to certain critically ill COVID-19 patients in the U.S. 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 multicenter 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. The data have been published in The Lancet Respiratory Medicine.
Gohibic is currently the only drug directed against the complement factor C5a that is authorized for the treatment of certain critically ill COVID-19 patients. InflaRx is continuing discussions with the FDA related to the submission of a Biologics License Application (BLA) for a potential future full approval of Gohibic.
Dr. Thomas Taapken, Chief Financial Officer of InflaRx, commented: “We have built an excellent core commercial team to support the launch and distribution to U.S. hospitals. We also have worked out a time- and cost-efficient model for distribution. We continue to adapt our investments to create a commercial and logistical infrastructure as well as additional manufacturing capacity.”
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 Authorization Application with the European Medicines Agency (EMA). The Company will provide updates on the status of regulatory submissions in the U.S. and elsewhere once available.
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