Gohibic FDA Approval Status
Last updated by Judith Stewart, BPharm on April 4, 2023.
FDA Approved: No (Emergency Use Authorization)
Brand name: Gohibic
Generic name: vilobelimab
Dosage form: Injection
Company: InflaRx N.V.
Treatment for: COVID-19
Gohibic (vilobelimab) is a monoclonal anti-human complement factor C5a antibody authorized under an Emergency Use Authorization (EUA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
- Gohibic (vilobelimab) is an investigational drug that has not been approved by the FDA for any indication, including for the treatment of COVID-19. There is limited information known about the safety and effectiveness of using Gohibic to treat hospitalized patients with COVID-19.
- Gohibic is the first authorized drug to control complement factor C5a, a protein that is part of the complement system which is activated as part of the body's innate immune response to invading pathogens.
- Gohibic is a monoclonal IgG4-kappa antibody that works by binding to C5a to block its interaction with the C5a receptor, effectively blocking the biological activity of C5a. By blocking C5a, Gohibic works to control the inflammatory response driven tissue and organ damage in severe COVID-19.
- Gohibic is administered via intravenous infusion over a period of 30 - 60 minutes for a maximum of six doses. Treatment should be started within 48 hours of intubation (Day 1) followed by administration on Days 2, 4, 8, 15 and 22 for as long as the patient is hospitalized (even if discharged from ICU).
- Warnings and precautions associated with Gohibic include an increased risk of serious infections and hypersensitivity reactions.
- The most common adverse reactions (incidence ≥3%) include 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.
- In addition to development in COVID-19, vilobelimab is also being developed for various debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum and cutaneous squamous cell carcinoma.
Development timeline for Gohibic
Further information
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