eculizumab   Click here for help

GtoPdb Ligand ID: 6884

Synonyms: h5G1.1 | h5G1.1VHC | Soliris®
Approved drug Immunopharmacology Ligand
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 (SB12; Epysqli®) was approved by the EMA in May 2023.
BOW080 (Polpharma Biologics, formerly Epirus Biopharmaceuticals) was in development, but this project appears to have been discontinued.
Immunopharmacology Comments
Included in GtoImmuPdb as it acts on the complement system, at the terminal step involved in membrane attack complex formation. The evidence confirming C5, C5a and the C5a receptor as anti-inflammatory drug targets is reviewed by Horiuchi and Tsukamoto (2016) [2].
Immunopharmacology Disease
Disease X-Refs Comment References
Neuromyelitis optica Disease Ontology: DOID:8869
OMIM: 600308
Orphanet: ORPHA71211
FDA approved drug for NMO patients with anti-AQP4 autoantibodies (granted in June 2019). 3
Myasthenia gravis Disease Ontology: DOID:437
OMIM: 254200
Orphanet: ORPHA589
Approved to treat generalized myasthenia gravis in patients with anti-acetylcholine receptor autoantibodies (granted in 2017 by FDA)