FDA grants EUA for vilobelimab in patients critically ill with COVID-19
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Key takeaways:
- A supporting study showed vilobelimab-treated patients demonstrated a lower chance of death.
- Vilobelimab is approved under an emergency use authorization when it is started within 48 hours of ventilation or life support initiation.
The FDA has granted an emergency use authorization for the monoclonal antibody vilobelimab in the treatment of patients with COVID-19 who have undergone ventilation or are on life support, according to a press release from the agency.
“COVID-19 treatments remain a priority for [the FDA Center for Drug Evaluation and Research (CDER)], as the disease continues to impact the lives of Americans,” Patrizia Cavazzoni, MD, director of the CDER, said in the release. “Today's authorization offers another potentially life-saving treatment option for the sickest COVID-19 patients.”
According to the release, vilobelimab (Gohibic, InflaRx) is approved under an emergency use authorization when it is started within 48 hours of a patient initiating ventilation or life support. The drug should be administered by an intravenous infusion at a dose of 800 mg. It can be given “up to six times” throughout the treatment period, the release said.
The emergency authorization is based on a study suggesting that patients receiving vilobelimab demonstrated a lower likelihood of mortality at 28 and 60 days, compared with patients who received placebo, according to the FDA. The most common adverse events in patients who receive vilobelimab include pneumonia, sepsis, delirium, pulmonary embolism and hypertension, the release said.
Vilobelimab is a first-in-class monoclonal antibody that targets the complement activation product C5a that preserves the membrane attack complex.
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