Pharma Focus Asia

InflaRx Announces FDA Emergency Use Authorisation for Gohibic (vilobelimab)

Wednesday, April 05, 2023

InflaRx announced that Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, has been granted an Emergency Use Authorisation (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of coronavirus disease 19 (COVID-19) in hospitalised adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody that has been granted an EUA for the treatment of COVID-19 in hospitalised adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).

Vilobelimab is the first authorised drug to control complement factor C5a, a protein that plays an important and often harmful role in the body´s immune response. Despite the availability of vaccines and other treatments for earlier disease stages of COVID-19, many patients are still developing viral sepsis and are progressing to critical status, which often requires invasive mechanical ventilation. As a result, according to the US Centres for Disease Control and Prevention, there are still about 2,000 deaths from COVID-19 per week in the US. This EUA brings new hope to these patients and make this important new treatment available to patients as rapidly as possible.

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