ENBREL
Enbrel (etanercept) is a tumor necrosis factor (TNF) blocker indicated for the treatment of several chronic inflammatory and autoimmune conditions in both adult and pediatric populations. In adults, it is used to manage rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Pediatric indications include polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients aged two and older, as well as plaque psoriasis in patients aged four and older. The therapy is utilized to reduce signs and symptoms, improve physical function, and inhibit the progression of structural damage in specific arthritic conditions.
How ENBREL Works
Etanercept is a dimeric soluble form of the p75 TNF receptor that binds to tumor necrosis factor (TNF), a cytokine that drives inflammatory and immune responses. By binding to TNF-alpha and TNF-beta, the drug prevents these molecules from attaching to receptors on the cell surface. This action renders the TNF biologically inactive, thereby interrupting the inflammatory processes that lead to joint pathology and skin symptoms. In vitro studies show that the drug does not cause the lysis of cells expressing transmembrane TNF.
Details
- Status
- Prescription
- First Approved
- 1998-11-02
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SYRINGE, VIAL
ENBREL Approval History
What ENBREL Treats
6 indicationsENBREL is approved for 6 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Plaque Psoriasis
- Polyarticular Juvenile Idiopathic Arthritis
- Juvenile Psoriatic Arthritis
ENBREL Boxed Warning
SERIOUS INFECTIONS and MALIGNANCIES WARNING: SERIOUS INFECTIONS and MALIGNANCIES See full prescribing information for complete boxed warning. SERIOUS INFECTIONS Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. ( 5.1 ) Enbrel should be discontinued if a patient develops a serious infection or sepsis during treatment. ( 5....
WARNING: SERIOUS INFECTIONS and MALIGNANCIES WARNING: SERIOUS INFECTIONS and MALIGNANCIES See full prescribing information for complete boxed warning. SERIOUS INFECTIONS Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. ( 5.1 ) Enbrel should be discontinued if a patient develops a serious infection or sepsis during treatment. ( 5.1 ) Perform test for latent TB; if positive, start treatment for TB prior to starting Enbrel. ( 5.1 ) Monitor all patients for active TB during treatment, even if initial latent TB test is negative. ( 5.1 ) MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, including Enbrel. ( 5.3 ) SERIOUS INFECTIONS Patients treated with Enbrel are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Enbrel should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patients for latent tuberculosis before Enbrel use and during therapy. Initiate treatment for latent infection prior to Enbrel use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infe
ENBREL Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
ENBREL Biosimilars
2 FDA-approved1 can be substituted at the pharmacy without calling the prescriber. The other 1 require prescriber approval to switch.
What are biosimilars? Lower-cost alternatives to ENBREL with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
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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.
ENBREL FDA Label Details
ProIndications & Usage
FDA Label (PDF)Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with: Rheumatoid Arthritis (RA) Psoriatic Arthritis (PsA) Ankylosing Spondylitis (AS) Plaque Psoriasis (PsO) Pediatric patients with: Polyarticular Juvenile Idiopathic Arthritis (pJIA), 2 years of age or older Juvenile Psoriatic Arthritis, 2 years of age or older (JPsA) Plaque Psoriasis, 4 years of age or older 1.1 Rheumatoid Arthritis Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function...
WARNING: SERIOUS INFECTIONS and MALIGNANCIES WARNING: SERIOUS INFECTIONS and MALIGNANCIES See full prescribing information for complete boxed warning. SERIOUS INFECTIONS Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.