CIMZIA
CIMZIA (certolizumab pegol) is a tumor necrosis factor (TNF) blocker indicated for the treatment of various chronic inflammatory and autoimmune conditions in adults and children. It is used to manage moderate-to-severe Crohn's disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and plaque psoriasis. Additionally, the medication is approved for pediatric patients aged two years and older with active polyarticular juvenile idiopathic arthritis. Its therapeutic role involves reducing signs and symptoms of these diseases and maintaining clinical response, particularly in patients who have not responded adequately to conventional therapies.
How CIMZIA Works
Certolizumab pegol functions by selectively binding to and neutralizing human tumor necrosis factor alpha (TNFα), a key pro-inflammatory cytokine that plays a central role in inflammatory processes. The drug neutralizes both membrane-associated and soluble forms of TNFα, thereby inhibiting the production of other inflammatory mediators like IL-1β. Unlike complete antibodies, certolizumab pegol does not contain a fragment crystallizable (Fc) region, which prevents it from fixing complement or causing antibody-dependent cell-mediated cytotoxicity. This targeted action helps suppress the overactive immune response responsible for tissue inflammation in the approved indications.
Details
- Status
- Prescription
- First Approved
- 2008-04-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
CIMZIA Approval History
What CIMZIA Treats
7 indicationsCIMZIA is approved for 7 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Crohn's Disease
- Rheumatoid Arthritis
- Polyarticular Juvenile Idiopathic Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Axial Spondyloarthritis
- Plaque Psoriasis
CIMZIA Boxed Warning
SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. CIMZIA should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: Active tube...
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. CIMZIA 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. Patients should be tested for latent tuberculosis before CIMZIA use and during therapy. Treatment for latent infection should be initiated prior to CIMZIA 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. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with CIMZIA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. MALIGNANCY Lymphoma and other malignancies, some fatal, have been
CIMZIA 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.
Drugs Similar to CIMZIA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
CIMZIA FDA Label Details
ProIndications & Usage
FDA Label (PDF)CIMZIA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy Treatment of adults with moderately to severely active rheumatoid arthritis Treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older Treatment of adult patients with active psoriatic arthritis. Treatment of adults with active ankylosing spondylitis Treatment of adults with active non...
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Most patients who developed these infection...
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.