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Label indication 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 ( 5.1 ) ]. FDA label
Also known as BG00002 (natalizumab), Natalizumab, Tysabri, natalizumab IV, natalizumab SC
BG00002 · 1 trial · 1 indication
AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Treatment-emergent AEs: events in participants who had received at least 1 dose of study drug, regardless of relationship to study drug.
For purposes of this analysis, the terms 'hypersensitivity' and 'drug hypersensitivity' were categorized by their temporal relationship to study drug infusion (within 2 hours of the start of the infusion), and were considered equivalent. Hypersensitivity reactions are defined as infusion reactions with the following preferred terms: hypersensitivity not otherwise specified (NOS), anaphylactic reaction, anaphylactoid reaction, dermatitis allergic, drug hypersensitivity, urticaria NOS, vasoconstriction, urticaria generalised, hypersensitivity, urticaria.
'Positive with unknown persistence' is defined as a positive result (≥0.5 micrograms/mL) at one timepoint only with no confirmatory re-test available at least 42 days later. 'Transient positive' is defined as a positive at one timepoint but negative upon re-test at least 42 days later. 'Persistent positive' is defined as positive at 2 or more timepoints separated by at least 42 days. The threshold for classifying a sample as 'antibody positive' was set at the lowest level of reactivity that had a measurable impact on drug serum concentrations.
| Arm | Type | Description |
|---|---|---|
| Natalizumab | EXPERIMENTAL | All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480. |
| Name | Type | Description |
|---|---|---|
| BG00002 (natalizumab) | BIOLOGICAL | - |
Inclusion Criteria: * MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and completed a Dosing Suspension Safety Evaluation (neurological examination and magnetic resonance imaging \[MRI\] scan) * Considered by the investigator to be free of signs a...
BG00002 is an investigational monoclonal antibody developed by Biogen Inc. (ticker BIIB) for relapsing-remitting multiple sclerosis, a form of multiple sclerosis characterized by episodes of new or worsening symptoms followed by recovery. It is being studied as a disease-modifying therapy in the neurology therapeutic area.
BG00002 is being developed for the treatment of relapsing-remitting multiple sclerosis. It is a monoclonal antibody designed to reduce disease activity in patients with this relapsing form of MS. The program is in Phase 3 clinical development and is not yet approved for commercial use.
BG00002 is developed by Biogen Inc., which trades under the ticker BIIB. Biogen is the sponsor of the clinical program evaluating the monoclonal antibody in relapsing-remitting multiple sclerosis. The company is responsible for the drug's development and regulatory strategy.
BG00002 is in Phase 3 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA for relapsing-remitting multiple sclerosis. The Phase 3 trial evaluating the drug has been completed, and the program remains in clinical development.
BG00002 has been evaluated in one Phase 3 clinical trial, NCT00306592, titled Natalizumab Re-Initiation of Dosing. The completed study enrolled 404 participants with relapsing-remitting multiple sclerosis across the United States and Canada. It was an uncontrolled trial that enrolled adults aged 18 years and older, both male and female.
Yes, BG00002 is also known as BG00002 (natalizumab). Natalizumab is the drug name associated with this Biogen program, and BG00002 is the company's designation for the same monoclonal antibody. Searches for either name refer to the same investigational therapy for relapsing-remitting multiple sclerosis.