Vilobelimab

Medication

US DailyMed: Vilobelimab

Routes of
administrationIntravenousATC code

None

Legal statusLegal status

US: ℞-only via emergency use authorization (EUA)^[1]^[2]^[3]^[4]

IdentifiersCAS Number

2250440-41-4

DrugBank

DB16416

UNII

F5T0RF9ZJA

KEGG

D11838

Chemical and physical dataFormulaC₆₄₅₆H₉₉₇₆N₁₇₁₆O₂₀₅₄S₄₄Molar mass145907.42 g·mol⁻¹

Vilobelimab, sold under the brand name Gohibic, is an investigational medication that is used for the treatment of COVID-19.^[1] It is a human-mouse chimeric IgG4 kappa antibody that targets human C5a in plasma.^[3]

The most common adverse reactions 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.^[1]

Vilobelimab is a recombinant chimeric monoclonal IgG4 antibody that specifically binds to the soluble human complement split product C5a after cleavage from C5 to block its interaction with the C5a receptor, both of which are components of the complement system thought to contribute to inflammation and worsening of COVID-19.^[2] Vilobelimab was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in April 2023.^[1]^[2]^[3]^[4]^[5]

Medical uses

Vilobelimab is authorized for use in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (artificial life support).^[1] Vilobelimab is not approved by the FDA for any indication, including for the treatment of COVID-19.^[2]

History

The clinical trial supporting the authorization showed that participants treated with Vilobelimab had a lower risk of death by day 28 and day 60 of treatment compared to placebo.^[1]

Society and culture

Names

Vilobelimab is the international nonproprietary name.^[6]

References

^ ^a ^b ^c ^d ^e ^f "FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19". U.S. Food and Drug Administration (FDA). 4 April 2023. Retrieved 4 April 2023. This article incorporates text from this source, which is in the public domain.
^ ^a ^b ^c ^d https://www.fda.gov/media/166823/download This article incorporates text from this source, which is in the public domain.
^ ^a ^b ^c https://www.fda.gov/media/166824/download
^ ^a ^b https://www.fda.gov/media/166826/download
^ "InflaRx Receives FDA Emergency Use Authorization for Gohibic (vilobelimab) for Treatment of Critically Ill COVID-19 Patients" (Press release). InflaRx N.V. 4 April 2023. Retrieved 4 April 2023 – via GlobeNewswire.
^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl:10665/340680.

External links

Clinical trial number NCT04333420 for "Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia (PANAMO)" at ClinicalTrials.gov

Monoclonal antibodies for infectious disease and toxins

Fungal

Human	Efungumab^†

Viral

Human	Ansuvimab Atoltivimab (+maftivimab/odesivimab) Avdoralimab^§ Bamlanivimab^† (+etesevimab)^† Bebtelovimab^§ Casirivimab^† (+imdevimab) Cilgavimab^† (+tixagevimab)^† Diridavumab^§ Etesevimab^† Exbivirumab^§ Foravirumab^§ Imdevimab^† (+casirivimab) Libivirumab^§ Maftivimab Nirsevimab^† Odesivimab Pemivibart Rafivirumab^§ Regavirumab^§ Regdanvimab Sevirumab^† Sotrovimab Suptavumab Tixagevimab^† (+cilgavimab)^† Tuvirumab^§
Chimeric	Cosfroviximab Larcaviximab Porgaviximab Vilobelimab^†
Humanized	Felvizumab^§ Lenvervimab^† Motavizumab^† Palivizumab Suvizumab^§