SYLVANT
SYLVANT (siltuximab) is an interleukin-6 (IL-6) antagonist indicated for the treatment of patients with multicentric Castleman's disease (MCD). The therapy is specifically for use in patients who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. It addresses the systemic manifestations of MCD that are linked to the overproduction of the IL-6 cytokine.
How SYLVANT Works
Siltuximab works by binding directly to human IL-6, a protein involved in normal physiologic processes such as immunoglobulin secretion. By binding to this cytokine, the drug prevents IL-6 from interacting with both soluble and membrane-bound IL-6 receptors. This blockade inhibits the signaling pathways that contribute to the clinical symptoms of multicentric Castleman's disease.
Details
- Status
- Prescription
- First Approved
- 2014-04-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SYLVANT Approval History
What SYLVANT Treats
1 indicationsSYLVANT is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multicentric Castleman's Disease
SYLVANT Target & Pathway
ProTarget
A cytokine involved in inflammation and immune regulation. Elevated IL-6 drives inflammation in rheumatoid arthritis and is linked to cytokine release syndrome. Blocking IL-6 or its receptor reduces inflammatory responses in autoimmune conditions.
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.
SYLVANT FDA Label Details
ProIndications & Usage
FDA Label (PDF)SYLVANT is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. SYLVANT is an interleukin-6 (IL-6) antagonist indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Limitations of Use SYLVANT was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study. Limita...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.