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  1. Drug Safety and Availability

FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19

[4/4/2023] FDA has issued an emergency use authorization (EUA) for the use of Gohibic (vilobelimab) injection for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (artificial life support).

The treatment targets a part of the immune system that is thought to play a role in the inflammation that leads to COVID-19 disease progression. The clinical trial supporting the authorization showed that patients treated with Gohibic had a lower risk of death by day 28 and day 60 of treatment compared to placebo.

“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 life-saving treatment option for the sickest COVID-19 patients.”

The recommended dosage of Gohibic is 800 mg administered by intravenous infusion after dilution, given up to six times over the treatment period. The most common adverse reactions with use of Gohibic are pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection, bronchopulmonary aspergillosis, hepatic enzyme increased, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratory tract infection, supraventricular tachycardia, constipation, and rash. Serious infections due to bacterial, fungal, or viral pathogens have been reported in patients with COVID-19 receiving Gohibic.

Additional safety information, dosing instructions, and potential side effects can be found in the authorized Fact Sheet for Health Care Providers. Additional information on authorized COVID-19 treatments is available on FDA’s Emergency Use Authorization webpage.

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