COSENTYX
Cosentyx (secukinumab) is an interleukin-17A antagonist indicated for the treatment of several chronic inflammatory conditions affecting the skin and joints. It is used in both adult and pediatric populations for moderate to severe plaque psoriasis, active psoriatic arthritis, and enthesitis-related arthritis. Additionally, the medication is approved for adults with active ankylosing spondylitis, non-radiographic axial spondyloarthritis, and moderate to severe hidradenitis suppurativa.
How COSENTYX Works
Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine. By binding to IL-17A, the drug inhibits the cytokine's ability to interact with the IL-17 receptor. This blockade prevents the subsequent release of proinflammatory cytokines and chemokines that contribute to inflammatory and immune responses.
Details
- Status
- Prescription
- First Approved
- 2015-01-21
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
COSENTYX Approval History
What COSENTYX Treats
6 indicationsCOSENTYX is approved for 6 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Moderate to severe plaque psoriasis in patients 6 years and older
- Active psoriatic arthritis in patients 2 years and older
- Active ankylosing spondylitis in adults
- Active non-radiographic axial spondyloarthritis with objective signs of inflammation in adults
- Active enthesitis-related arthritis in pediatric patients 4 years and older
- Moderate to severe hidradenitis suppurativa in adults
COSENTYX Target & Pathway
ProTarget
A pro-inflammatory cytokine produced by Th17 cells that plays a key role in psoriasis, psoriatic arthritis, and ankylosing spondylitis. Blocking IL-17 reduces the inflammatory cascade that causes skin plaques and joint inflammation.
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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.
COSENTYX FDA Label Details
ProIndications & Usage
FDA Label (PDF)COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in patients 6 years and older who are candidates for systemic therapy or phototherapy. active psoriatic arthritis (PsA) in patients 2 years of age and older. adults with active ankylosing spondylitis (AS) . adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. adults with moderate to severe hidradenitis suppurativa (HS). 1.1 Plaque ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.