TYSABRI
Tysabri (natalizumab) is an integrin receptor antagonist indicated as monotherapy for adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It is also used to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn's disease who show evidence of inflammation and have failed or cannot tolerate conventional therapies and TNF-α inhibitors. Because the drug increases the risk of progressive multifocal leukoencephalopathy (PML), physicians must determine if the expected benefits outweigh this risk. In the treatment of Crohn's disease, Tysabri must not be used in combination with other immunosuppressants or TNF-α inhibitors.
How TYSABRI Works
Natalizumab binds to the α4-subunit of α4β1 and α4β7 integrins expressed on the surface of most leukocytes, excluding neutrophils. This binding inhibits the adhesion of leukocytes to their receptors, such as VCAM-1 on the vascular endothelium and MAdCAM-1 in the gastrointestinal tract. By disrupting these molecular interactions, the drug prevents inflammatory cells from migrating across the endothelium into parenchymal tissue. In multiple sclerosis, this mechanism is believed to block activated inflammatory cells from crossing the blood-brain barrier, thereby reducing inflammatory activity in the brain.
Details
- Status
- Prescription
- First Approved
- 2004-11-23
- Routes
- SINGLE-USE
- Dosage Forms
- VIAL
TYSABRI Approval History
What TYSABRI Treats
2 indicationsTYSABRI is approved for 2 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Relapsing forms of multiple sclerosis (clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease)
- Moderately to severely active Crohn's disease
TYSABRI Boxed Warning
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYSABRI [ see Warnings...
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYSABRI [ see Warnings and Precautions ( 5.1 ) ]. Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML. TYSABRI dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation that includes a gadolinium-enhanced magnetic resonance imaging (MRI) scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended [ see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ) ]. Because of the risk of PML, TYSABRI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH ® Prescribing Program [ see Warnings and Precautions ( 5.2 ) ]. WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability ( 5.1 ) Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYSABRI ( 5.1 ) Monitor patients, and withhold TYSABRI immediately at the first sign or symptom suggestive of PML ( 4 , 5.1 ) Because of the risk of PML, TYSABRI is available only through a restricted distributi
TYSABRI Biosimilars
1 FDA-approvedThese 1 alternatives require prescriber approval to substitute for TYSABRI.
What are biosimilars? Lower-cost alternatives to TYSABRI with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
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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.
TYSABRI FDA Label Details
ProIndications & Usage
FDA Label (PDF)TYSABRI is an integrin receptor antagonist indicated for treatment of: Multiple Sclerosis (MS) TYSABRI is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TYSABRI increases the risk of PML [See Warnings and Precautions ]. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk. Crohn's Disease (CD) TYSABRI is indicated for inducing and mai...
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include the presence of anti-JCV...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.