Overview
Sarilumab is a fully human anti-interleukin 6 (IL-6) receptor monoclonal IgG1 antibody that binds to both membrane-bound and soluble IL-6 receptor forms, thus blocking the cis- and trans-inflammatory signalling cascades of IL-6. Sarilumab was developed by Sanofi and Regeneron Pharmaceuticals, Inc; it was US FDA-approved in May 2017 and followed by EU approval in June 2017 for the treatment of moderate to severe rheumatoid arthritis (RA) in combination with methotrexate. RA is a chronic inflammatory disease characterized by polyarthritis, and its treatment has been challenged by the different responses in every patient. Subcutaneous administration of sarilumab has been shown to decrease acute-phase reactant levels and improve clinical RA symptoms.
Indication
Sarilumab is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs); and adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.
Associated Conditions
- Polymyalgia Rheumatica (PMR)
- Moderate, active Rheumatoid arthritis
- Severe, active Rheumatoid arthritis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/22 | Phase 2 | Recruiting | |||
2023/01/30 | Phase 1 | Active, not recruiting | |||
2022/09/10 | Phase 2 | Recruiting | John Harris | ||
2022/06/22 | Phase 2 | Recruiting | |||
2021/11/18 | Phase 1 | Recruiting | |||
2021/04/13 | Phase 1 | Terminated | |||
2020/12/10 | Phase 2 | UNKNOWN | Clinica Universidad de Navarra, Universidad de Navarra | ||
2020/10/19 | Phase 1 | Recruiting | |||
2020/05/13 | Early Phase 1 | Withdrawn | |||
2020/04/22 | Phase 2 | Completed | Maria del Rosario Garcia de Vicuña Pinedo |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sanofi-Aventis U.S. LLC | 0024-5910 | SUBCUTANEOUS | 200 mg in 1.14 mL | 2/28/2023 | |
| sanofi-aventis U.S. LLC | 0024-5910 | SUBCUTANEOUS | 200 mg in 1.14 mL | 2/28/2023 | |
| Sanofi-Aventis U.S. LLC | 0024-5920 | SUBCUTANEOUS | 150 mg in 1.14 mL | 2/28/2023 | |
| sanofi-aventis U.S. LLC | 0024-5920 | SUBCUTANEOUS | 150 mg in 1.14 mL | 2/28/2023 | |
| Sanofi-Aventis U.S. LLC | 0024-5922 | SUBCUTANEOUS | 200 mg in 1.14 mL | 2/28/2023 | |
| sanofi-aventis U.S. LLC | 0024-5922 | SUBCUTANEOUS | 200 mg in 1.14 mL | 2/28/2023 | |
| Sanofi-Aventis U.S. LLC | 0024-5908 | SUBCUTANEOUS | 150 mg in 1.14 mL | 2/28/2023 | |
| sanofi-aventis U.S. LLC | 0024-5908 | SUBCUTANEOUS | 150 mg in 1.14 mL | 2/28/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/23/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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