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Anifrolumab

Generic Name
Anifrolumab
Brand Names
Saphnelo
Drug Type
Biotech
CAS Number
1326232-46-5
Unique Ingredient Identifier
38RL9AE51Q
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)

Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.

Phase 2
Completed
Conditions
Systemic Lupus Erythematosus
Interventions
First Posted Date
2012-03-21
Last Posted Date
2019-03-13
Lead Sponsor
AstraZeneca
Target Recruit Count
17
Registration Number
NCT01559090
Locations
🇯🇵

Research Site, Shinjuku-ku, Japan

A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma

Phase 1
Completed
Conditions
Scleroderma
Interventions
First Posted Date
2009-06-30
Last Posted Date
2012-05-08
Lead Sponsor
MedImmune LLC
Target Recruit Count
34
Registration Number
NCT00930683
Locations
🇺🇸

Boston University, Boston, Massachusetts, United States

🇺🇸

University of Utah Medical Center, Salt Lake City, Utah, United States

🇺🇸

Research Site, Seattle, Washington, United States

and more 1 locations
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