FDA Authorizes New Injection Treatment for COVID-19
WASHINGTON — The Food and Drug Administration on Tuesday issued an emergency use authorization for Gohibic (vilobelimab) injections to be used to treat COVID-19 in hospitalized adults.
The authorization allows for the use of the injection within 48 hours of a patient being placed on 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 the FDA’s Center for Drug Evaluation and Research, as the disease continues to impact the lives of Americans,” said Dr. Patrizia Cavazzoni, director of the agency.
“Today’s authorization offers another potentially lifesaving treatment option for the sickest COVID-19 patients,” she said.
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, increase of hepatic enzyme, 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.
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