SIMPONI
Simponi (golimumab) is a tumor necrosis factor (TNF) blocker indicated for the treatment of several chronic inflammatory and autoimmune conditions. It is approved for use in adult patients with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis. The medication is also indicated for adults and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis. Depending on the specific indication, Simponi may be used as a monotherapy or in combination with methotrexate.
How SIMPONI Works
Golimumab is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNFα. This binding prevents TNFα from interacting with its receptors, thereby inhibiting the biological activity of this proinflammatory cytokine. By blocking TNFα, the drug modulates the expression of adhesion proteins responsible for leukocyte infiltration and reduces the secretion of other proinflammatory cytokines. While this mechanism addresses the articular inflammation characteristic of several chronic diseases, the exact mechanism for treating ulcerative colitis is unknown.
Details
- Status
- Prescription
- First Approved
- 2009-04-24
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SIMPONI Approval History
What SIMPONI Treats
4 indicationsSIMPONI is approved for 4 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Ulcerative colitis
SIMPONI Boxed Warning
SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving SIMPONI ( 5.1 ) Discontinue SIMPONI if a patient develops a serious infection or sepsis ( 5.1 ) Perform test for latent TB; if positive, start trea...
WARNING: SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving SIMPONI ( 5.1 ) Discontinue SIMPONI if a patient develops a serious infection or sepsis ( 5.1 ) Perform test for latent TB; if positive, start treatment for TB prior to starting SIMPONI ( 5.1 ) Monitor all patients for active TB during treatment, even if initial latent TB test is negative ( 5.1 ) Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which SIMPONI is a member ( 5.2 ) SERIOUS INFECTIONS Patients treated with SIMPONI are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue SIMPONI if a patient develops a serious infection. Reported infections with TNF blockers, of which SIMPONI is a member, 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 SIMPONI use and during therapy. Initiate treatment for latent TB prior to SIMPONI 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 infection. Consider empiric antifungal therapy in patients at ri
SIMPONI 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.
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Active Pipeline
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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.
SIMPONI FDA Label Details
ProIndications & Usage
FDA Label (PDF)SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate adult patients with active ankylosing spondylitis (AS) adult and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis (UC) 1.1 Rheumatoid Arthritis SIMPONI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely ac...
WARNING: SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.