BENLYSTA
BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients aged five years and older. It is used in conjunction with standard therapy for the management of active systemic lupus erythematosus (SLE) and active lupus nephritis. The medication is not recommended for use in patients with severe active central nervous system lupus, as its efficacy has not been evaluated in this population.
How BENLYSTA Works
BENLYSTA functions by blocking the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells. While the drug does not bind to B cells directly, its inhibition of BLyS prevents the survival of B cells, including autoreactive B cells. This process reduces the differentiation of B cells into plasma cells that produce immunoglobulins.
Details
- Status
- Prescription
- First Approved
- 2011-03-09
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
BENLYSTA Approval History
What BENLYSTA Treats
2 indicationsBENLYSTA is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Systemic Lupus Erythematosus
- Lupus Nephritis
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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.
BENLYSTA FDA Label Details
ProIndications & Usage
FDA Label (PDF)BENLYSTA is indicated for the treatment of patients 5 years of age and older with: • Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and • Active lupus nephritis who are receiving standard therapy. Limitations of Use The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus. Use of BENLYSTA is not recommended in this situation. BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients 5 years of age and older with: • Active systemic lupus erythematosus (SLE) who a...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.