The US FDA has granted emergency use authorization (EUA) to vilobelimab for use in patients who are critically ill with Covid-19 making way for a potentially life-saving treatment for such patients. Vilobelimab is a monoclonal anti-human complement factor C5a antibody. It is available as 200 mg/20 mL single-dose vials for further dilution. The authorization was granted based on the results of the phase 3 PANAMO trial conducted in patients with severe Covid-19 pneumonia wherein addition of vilobelimab to standard treatment reduced the all-cause mortality at 28 days compared to placebo and standard of care; 32% vs 42%

Indication: Hospitalized adult patients with Covid-19 on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

Dosage and administration: 800 mg IV infusion after dilution for a maximum of 6 doses; it must be administered within 48 hours of receiving intubation as Day 1, followed by further doses on Days 2, 4, 8, 15 and 22

Contraindication: No contraindications have been identified so far (limited data for EUA)

Warning and precautions: Hypersensitivity reactions, increased risk of serious bacterial, fungal, or viral infections

Side effects: 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.

Sources

1. https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-gohibic-vilobelimab-injection-treatment-covid-19, 4/4/2023. Accessed on April 5, 2023.
2. Fact sheet for healthcare providers: emergency use authorization for Gohibic.  Available at: https://www.fda.gov/media/166824/download. Accessed on April 5, 2023.
3. Novel drug authorized for critically ill COVID-19 patients. https://www.medpagetoday.com/infectiousdisease/covid19/103866. April 4, 2023. Accessed on April 5, 2023.