The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to InflaRx’s Gohibic (vilobelimab) to treat critically ill hospitalised Covid-19 adult patients.
Gohibic is indicated for use in these patients within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).
It is a first-in-class monoclonal anti-human complement factor C5a antibody.
InflaRx CEO and founder Niels Riedemann said: “We are thrilled and very proud that the FDA has issued an EUA for vilobelimab to treat this very sick patient group, recognising the lifesaving potential of this first-in-class drug. 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 consequence, we continue to see mortality rates in the range of approximately 2,000 Covid-19-reported deaths per week in the US, as reported by the US Centers for Disease Control and Prevention.”
The regulator granted the EUA based on data obtained from the multicentre Phase III PANAMO trial, which was conducted in Covid-19 patients who are invasively mechanically ventilated in intensive care units.
According to the findings, the treatment with vilobelimab improved survival rates, with a 23.9% significant relative reduction in 28-day all-cause mortality compared to a placebo.
The company is continuing talks with the FDA to discuss further steps for the Biologics License Application (BLA) submission for complete approval of Gohibic.
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