Vilobelimab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Chimeric |
| Target | Complement component 5a (C5a) |
| Clinical data | |
| Trade names | Gohibic |
| Other names | IFX-1 |
| License data |
|
| Routes of administration | Intravenous |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6456H9976N1716O2054S44 |
| Molar mass | 145907.42 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
In the US, 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
Legal status
In November 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization under exceptional circumstances for the medicinal product Gohibic intended for the treatment of adults with SARS‑CoV2‑induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids.[6] The applicant for this medicinal product is InflaRx GmbH.[6][7]
Names
Vilobelimab is the international nonproprietary name.[8]
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.
- ^ a b "Gohibic EPAR". European Medicines Agency (EMA). 14 November 2024. Retrieved 16 November 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2024". European Medicines Agency (EMA). 15 November 2024. Retrieved 16 November 2024.
- ^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl:10665/340680.
Further reading
- Vlaar AP, Witzenrath M, van Paassen P, Heunks LM, Mourvillier B, de Bruin S, et al. (December 2022). "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. doi:10.1016/S2213-2600(22)00297-1. PMC 9451499. PMID 36087611.
External links
- Clinical trial number NCT04333420 for "Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia (PANAMO)" at ClinicalTrials.gov
