Vilobelimab Explained

Type:	mab
Mab Type:	mab
Source:	xi
Target:	C5a (C5a)
Tradename:	Gohibic
Dailymedid:	Vilobelimab
Routes Of Administration:	Intravenous
Atc Prefix:	None
Legal Us:	Rx-only
Legal Us Comment:	via emergency use authorization (EUA)
Cas Number:	2250440-41-4
Drugbank:	DB16416
Unii:	F5T0RF9ZJA
Kegg:	D11838
Synonyms:	IFX-1
C:	6456
H:	9976
N:	1716
O:	2054
S:	44

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.

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.

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. Vilobelimab was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in April 2023.^{[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). Vilobelimab is not approved by the FDA for any indication, including for the treatment of COVID-19.

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.

Society and culture

Names

Vilobelimab is the international nonproprietary name.^[6]

Further reading

• Vlaar AP, Witzenrath M, van Paassen P, Heunks LM, Mourvillier B, de Bruin S, Lim EH, Brouwer MC, Tuinman PR, Saraiva JF, Marx G, Lobo SM, Boldo R, Simon-Campos JA, Cornet AD, Grebenyuk A, Engelbrecht JM, Mukansi M, Jorens PG, Zerbib R, Rückinger S, Pilz K, Guo R, van de Beek D, Riedemann NC . 6 . Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial . The Lancet. Respiratory Medicine . 10 . 12 . 1137–1146 . December 2022 . 36087611 . 9451499 . 10.1016/S2213-2600(22)00297-1 . free . doi .

Notes and References

1. Web site: FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19 . U.S. Food and Drug Administration (FDA) . 4 April 2023 . 4 April 2023.
2. https://www.fda.gov/media/166823/download
3. https://www.fda.gov/media/166824/download
4. https://www.fda.gov/media/166826/download
5. InflaRx Receives FDA Emergency Use Authorization for Gohibic (vilobelimab) for Treatment of Critically Ill COVID-19 Patients . InflaRx N.V. . GlobeNewswire . 4 April 2023 . 4 April 2023.
6. ((World Health Organization)) . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84 . WHO Drug Information . 34 . 3 . 2020 . 10665/340680 . free . World Health Organization .