FDA Authorizes New Monoclonal Antibody for COVID-19

InflaRx N.V. today announced that Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, has been granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (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).

The FDA granted EUA based on Phase 3 clinical trial results showing a significant relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in critically IMV COVID-19 patients.

As of January 26, 2023, the FDA had withdrawn its EUA(s) for monoclonal antibodies (mAbs) for COVID-19.

“COVID-19 treatments remain a priority for CDER, as the disease continues to impact the lives of Americans,” said Center Director Patrizia Cavazzoni, M.D. “Today's authorization offers another potentially lifesaving treatment option for the sickest COVID-19 patients.”

The Annals of Internal Medicine recently published results from a study that concluded early mAb treatment among outpatients with COVID-19 was associated with a lower risk of hospitalization or death.

Prof. Niels C. Riedemann, CEO and Founder of InflaRx, commented in a press release on April 4, 2023, "We are thrilled and very proud that the FDA has issued a EUA for vilobelimab to treat this very sick patient group, recognizing 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 U.S., as reported by the U.S. Centers for Disease Control and Prevention."

"Today's announcement brings new hope to these patients and their loved ones, and we will work diligently to make this important new treatment available to patients as rapidly as possible."

InflaRx stated it plans to apply for full approval to treat critically ill COVID-19 patients in Europe.

Additional mAbs news is posted at CoronavirusToday.com.