Overview
Eculizumab is a monoclonal antibody that targets complement protein C5. Binding to this protein prevents the activation of a complement terminal complex, which is used to treat a number of autoimmune conditions. Eculizumab was granted FDA approval on 16 March 2007. In Q1 2023, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of two formulations of eculizumab indicated for the treatment of paroxysmal nocturnal hemoglobinuria.
Indication
Eculizumab is indicated in the US to treat paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy, and neuromyelitis optica spectrum disorder (NMOSD). It is also indicated in EU to treat PNH in both adult and pediatric patients.
Associated Conditions
- Generalized Myasthenia Gravis
- Neuromyelitis Optica Spectrum Disorders
- Paroxysmal Nocturnal Haemoglobinuria (PNH)
- Thrombotic Microangiopathies
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/08 | Phase 4 | Not yet recruiting | |||
2025/05/23 | Phase 3 | Completed | |||
2025/04/17 | Phase 3 | Recruiting | |||
2025/03/21 | N/A | Completed | |||
2025/01/29 | Phase 3 | Recruiting | Haisco Pharmaceutical Group Co., Ltd. | ||
2025/01/08 | Phase 3 | Active, not recruiting | |||
2024/12/09 | Phase 3 | Recruiting | |||
2024/09/19 | Phase 3 | Active, not recruiting | |||
2024/07/22 | Phase 2 | Completed | |||
2024/06/11 | Phase 1 | Not yet recruiting | Tao Lin |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Alexion Pharmaceuticals Inc. | 25682-001 | INTRAVENOUS | 300 mg in 30 mL | 3/28/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/19/2023 | ||
Authorised | 6/20/2007 | ||
Authorised | 5/26/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Soliris Concentrate for Solution for Infusion 300mg/vial | SIN14226P | INFUSION, SOLUTION CONCENTRATE | 300 mg / vial | 9/12/2012 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Eculizumab Injection | 国药准字SJ20180023 | 生物制品 | 注射剂 | 7/17/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SOLIRIS eculizumab (rmc) 300 mg/30 mL concentrated solution for intravenous infusion vial | 138885 | Medicine | A | 3/20/2009 |
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