Overview
Anifrolumab, or MEDI-546, is a type 1 interferon receptor (IFNAR) inhibiting IgG1κ monoclonal antibody indicated in the treatment of adults with moderate to severe systemic lupus erythematosus. The standard therapy for systemic lupus erythematosus consists of antimalarials like hydroxychloroquine, glucocorticoids like dexamethasone, and disease modifying antirheumatic drugs like methotrexate. Three monoclonal antibodies (anifrolumab, rontalizumab, and sifalimumab) that target the type 1 interferon pathway entered clinical trials as potential treatments for systemic lupus erythematosus, but so far only anifrolumab has been approved. The design of early clinical trials of anti-interferon treatments such as anifrolumab, rontalizumab, and sifalimumab have come under criticism. The design of the clinical trials use different definitions of autoantibody positivity, making comparison between trials difficult; all trials involve large portions of patients also using corticosteroids, which may alter patient responses in the experimental and placebo groups; and patient populations were largely homogenous, which may have increased the odds of success of the trial. Anifrolumab has also been investigated for the treatment of Scleroderma. Anifrolumab was granted FDA approval on 30 July 2021.
Background
Anifrolumab, or MEDI-546, is a type 1 interferon receptor (IFNAR) inhibiting IgG1κ monoclonal antibody indicated in the treatment of adults with moderate to severe systemic lupus erythematosus. The standard therapy for systemic lupus erythematosus consists of antimalarials like hydroxychloroquine, glucocorticoids like dexamethasone, and disease modifying antirheumatic drugs like methotrexate. Three monoclonal antibodies (anifrolumab, rontalizumab, and sifalimumab) that target the type 1 interferon pathway entered clinical trials as potential treatments for systemic lupus erythematosus, but so far only anifrolumab has been approved. The design of early clinical trials of anti-interferon treatments such as anifrolumab, rontalizumab, and sifalimumab have come under criticism. The design of the clinical trials use different definitions of autoantibody positivity, making comparison between trials difficult; all trials involve large portions of patients also using corticosteroids, which may alter patient responses in the experimental and placebo groups; and patient populations were largely homogenous, which may have increased the odds of success of the trial. Anifrolumab has also been investigated for the treatment of Scleroderma. Anifrolumab was granted FDA approval on 30 July 2021.
Indication
Anifrolumab is indicated in the treatment of adults with moderate to severe systemic lupus erythematosus.
Associated Conditions
- Moderate Systemic Lupus Erythematosus (SLE)
- Severe Systemic Lupus Erythematosus (SLE)
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/06/30 | Phase 2 | Recruiting | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||
2024/11/01 | Phase 2 | Not yet recruiting | |||
2022/04/21 | Phase 1 | Completed | |||
2021/11/30 | Phase 3 | Recruiting | |||
2021/06/18 | Phase 3 | Active, not recruiting | |||
2021/05/07 | Phase 3 | Active, not recruiting | |||
2021/02/11 | N/A | NO_LONGER_AVAILABLE | |||
2021/01/27 | Early Phase 1 | Recruiting | |||
2018/02/19 | Phase 2 | UNKNOWN | Josef Smolen, Univ. Prof. Dr. | ||
2016/11/15 | Phase 2 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||