InflaRx’s Gohibic is indicated to treat hospitalised Covid-19 adult patients within 48 hours of receiving invasive mechanical ventilation. Credit: engin akyurt on Unsplash.

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).

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.