SILIQ
SILIQ (brodalumab) is an interleukin-17 receptor A (IL-17RA) antagonist indicated for the treatment of moderate to severe plaque psoriasis in adult patients. It is specifically intended for individuals who are candidates for systemic therapy or phototherapy. The medication serves as a therapeutic option for patients who have either failed to respond or have lost response to other systemic therapies.
How SILIQ Works
Brodalumab is a human monoclonal IgG2 antibody that selectively binds to human IL-17RA, a protein expressed on the cell surface. By binding to this receptor, the drug inhibits interactions with multiple cytokines, including IL-17A, IL-17F, IL-17C, the IL-17A/F heterodimer, and IL-25. This blockade prevents the IL-17 cytokine-induced release of pro-inflammatory cytokines and chemokines.
Details
- Status
- Prescription
- First Approved
- 2017-02-15
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SILIQ Approval History
What SILIQ Treats
1 indicationsSILIQ is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Plaque Psoriasis
SILIQ Boxed Warning
SUICIDAL IDEATION AND BEHAVIOR Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicid...
WARNING: SUICIDAL IDEATION AND BEHAVIOR Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes [ see Warnings and Precautions ( 5.1 ) ]. Because of the observed suicidal behavior in subjects treated with SILIQ, SILIQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program [see Warnings and Precautions ( 5.2 ) ]. WARNING: SUICIDAL IDEATION AND BEHAVIOR See full prescribing information for complete boxed warning. Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. ( 5.1 , 6.1 ) Prior to prescribing, weigh potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. ( 5.1 ) Patients with new or worsening suicidal thoughts and behavior should be referred to a mental health professional, as appropriate. ( 5.1 ) Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes. ( 5.1 ) SILIQ is available only through a restricted program called the SILIQ REMS Program. ( 5.2 )
SILIQ 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.
SILIQ FDA Label Details
ProIndications & Usage
FDA Label (PDF)SILIQ ® (brodalumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. SILIQ is a human interleukin-17 receptor A (IL-17RA) antagonist indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.
WARNING: SUICIDAL IDEATION AND BEHAVIOR Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patien...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.