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Synonyms: h5G1.1 | h5G1.1VHC | Soliris®
eculizumab is an approved drug (FDA (2011), EMA (2007))
Compound class:
Antibody
Comment: Eculizumab is a humanized monoclonal antibody targeting terminal complement activation, by binding to complement component C5 and inhibiting the production of C5a [4]. It is the first approved therapy for paroxysmal nocturnal hemoglobinuria.
Eculizumab's developers, Alexion Pharmaceuticals have developed a next-generation version of eculizumab called ravulizumab (ALXN1210; FDA approved in December 2018), that has a longer circulating half-life than the originator, which allows for monthly dosing. The evidence confirming C5, C5a and the C5a receptor as anti-inflammatory and anti-cancer drug targets is reviewed by Horiuchi and Tsukamoto (2016) [2]. Biosimilars: Amgen's biosimilar ABP 959 (eculizumab-aeeb; Bekemv®) was approved by the EMA in April 2023. This was approved as an interchangeable biosimilar to Soliris® by the FDA in May 2024. Samsung Bioepis' biosimilar (eculizumab-aagh; SB12; Epysqli®) was approved by the EMA in May 2023, and by the FDA in July 2024. BOW080 (Polpharma Biologics, formerly Epirus Biopharmaceuticals) was in development, but this project appears to have been discontinued. |
Classification  |
|
| Compound class | Antibody |
| Approved drug? | Yes (FDA (2011), EMA (2007)) |
| International Nonproprietary Names |
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| INN number | INN |
| 8231 | eculizumab |
| Synonyms |
| h5G1.1 | h5G1.1VHC | Soliris® |
| Database Links |
|
| Specialist databases | |
| IMGT/mAb-DB | 37 |
| Other databases | |
| GtoPdb PubChem SID | 178103466 |
| PubChem SID | 178103466 |
| Search PubMed clinical trials | eculizumab |
| Search PubMed titles | eculizumab |
| Search PubMed titles/abstracts | eculizumab |
| Wikipedia | Eculizumab |
