Overview
Natalizumab is a recombinant humanized IgG4κ monoclonal antibody that binds to α4-integrin. While natalizumab was originally approved by the FDA to treat multiple sclerosis in 2004, it was withdrawn from the market following multiple reports of fatal progressive multifocal leukoencephalopathy (PML). In 2006, the FDA reintroduced the drug to the market for multiple sclerosis. Natalizumab was further approved by the FDA for the treatment of Crohn's Disease in January 2008. On August 24, 2023, the first biosimilar to natalizumab, natalizumab-sztn, was approved by the FDA.
Background
Natalizumab is a recombinant humanized IgG4κ monoclonal antibody that binds to α4-integrin. While natalizumab was originally approved by the FDA to treat multiple sclerosis in 2004, it was withdrawn from the market following multiple reports of fatal progressive multifocal leukoencephalopathy (PML). In 2006, the FDA reintroduced the drug to the market for multiple sclerosis. Natalizumab was further approved by the FDA for the treatment of Crohn's Disease in January 2008. On August 24, 2023, the first biosimilar to natalizumab, natalizumab-sztn, was approved by the FDA.
Indication
Natalizumab is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. It is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to or are unable to tolerate, conventional therapies and inhibitors of TNF-α. It is not to be used in combination with immunosuppressants or inhibitors of TNF-α.
Associated Conditions
- Relapsing Remitting Multiple Sclerosis (RRMS)
- Secondary Progressive Multiple Sclerosis (SPMS)
- Severe Crohn's Disease
- Moderate Crohn’s Disease
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/26 | N/A | Completed | |||
2023/06/29 | N/A | Active, not recruiting | |||
2023/01/27 | N/A | Active, not recruiting | |||
2023/01/18 | N/A | Recruiting | |||
2022/11/16 | Phase 1 | Active, not recruiting | |||
2022/09/08 | Phase 4 | Terminated | |||
2022/06/14 | Phase 2 | Suspended | |||
2022/03/31 | N/A | Completed | |||
2022/03/03 | Phase 3 | Terminated | |||
2022/02/11 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Biogen Inc. | 64406-008 | INTRAVENOUS | 300 mg in 15 mL | 6/22/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/22/2023 | ||
Authorised | 6/27/2006 | ||
Authorised | 6/27/2006 | ||
Authorised | 6/27/2006 | ||
Authorised | 6/27/2006 | ||
Authorised | 9/22/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Tysabri Concentrate for Solution for Infusion 300mg/15ml | SIN14408P | INFUSION, SOLUTION CONCENTRATE | 300 mg/15mL | 9/11/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TYSABRI CONCENTRATE FOR SOLUTION FOR INFUSION 300MG | N/A | N/A | N/A | 11/12/2012 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TYSABRI natalizumab 300mg/15 mL concentrate for infusion vial | 112372 | Medicine | A | 11/1/2006 | |
| TYSABRI natalizumab 150 mg/1 mL injection solution pre-filled syringe | 353845 | Medicine | A | 12/7/2021 | |
| TYRUKO natalizumab 300 mg/15 mL concentrate for infusion vial | 425612 | Medicine | A | 4/4/2025 |