SAPHNELO
Saphnelo (anifrolumab-fnia) is a type I interferon receptor antagonist indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. It serves as a targeted therapeutic option for patients with active disease, particularly as many patients with SLE express elevated levels of type I interferon-inducible genes. The drug is not recommended for use in patients with severe active lupus nephritis or severe active central nervous system lupus, as its efficacy has not been evaluated in these populations.
How SAPHNELO Works
Anifrolumab-fnia is a monoclonal antibody that binds to subunit 1 of the type I interferon receptor (IFNAR), blocking the signaling and biological activity of type I interferons. This inhibition suppresses the expression of interferon-responsive genes and reduces downstream inflammatory and immunological processes, such as plasma cell differentiation. The drug also induces the internalization of the receptor, which decreases the amount of IFNAR1 available on the cell surface. These combined actions help normalize peripheral T-cell subsets and address the biological pathways involved in the pathogenesis of SLE.
Details
- Status
- Prescription
- First Approved
- 2021-07-30
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SAPHNELO Approval History
What SAPHNELO Treats
1 indicationsSAPHNELO is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Systemic Lupus Erythematosus
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SAPHNELO FDA Label Details
ProIndications & Usage
FDA Label (PDF)SAPHNELO (anifrolumab-fnia) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy [see Clinical Studies ] . Limitations of Use The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations. SAPHNELO is a type I interferon (IFN) receptor antagonist indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving sta...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.