The FDA authorized Gohibic (vilobelimab) for emergency use as a COVID-19 treatment for some hospitalized adults.
Gohibic, made by Germany-based company InflaRx, is authorized to treat COVID-19 in hospitalized adults within 48 hours of "receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (artificial life support)," the FDA said April 4.
Healthcare providers providing the diluted drug are instructed to administer 800 milligrams by intravenous infusion for 30 to 60 minutes for up to six doses, according to the FDA's fact sheet. The drug is intended to be taken on day two, four, eight, 15 and 22 "as long as the patient is still hospitalized (even if discharged from ICU)."
Compared to a placebo, patients who took Gohibic in a trial had a lower risk of death after one month and two months of treatment, the agency said.
The five most common adverse reactions, which were reported in less than 3 percent of study participants, were pneumonia, sepsis, delirium, pulmonary embolism and hypertension. Also, "serious infections due to bacterial, fungal or viral pathogens have been reported in patients with COVID-19 receiving Gohibic," the FDA said.