SPEVIGO
Spevigo (spesolimab-sbzo) is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis (GPP). The medication is approved for use in adults as well as pediatric patients 12 years of age and older who weigh at least 40 kg. It serves as a targeted therapeutic option for managing this condition in these specific patient populations.
How SPEVIGO Works
Spesolimab-sbzo is a humanized monoclonal immunoglobulin G1 antibody that binds specifically to the interleukin-36 receptor (IL36R). This binding prevents the receptor from being activated by its ligands, which include IL-36 alpha, beta, and gamma. By inhibiting this signaling, the drug blocks the downstream activation of pro-inflammatory and pro-fibrotic pathways.
Details
- Status
- Prescription
- First Approved
- 2022-09-01
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
SPEVIGO Approval History
What SPEVIGO Treats
1 indicationsSPEVIGO is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Generalized Pustular Psoriasis
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.
SPEVIGO FDA Label Details
ProIndications & Usage
FDA Label (PDF)SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. SPEVIGO is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.