BRIUMVI
BRIUMVI (ublituximab-xiiy) is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. This indication encompasses patients with clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The drug provides a targeted therapeutic approach for managing these specific classifications of MS.
How BRIUMVI Works
Ublituximab-xiiy binds to CD20, a cell surface antigen found on pre-B and mature B lymphocytes. Once the drug binds to these lymphocytes, it induces cell lysis, which is the breakdown and destruction of the cell. This therapeutic effect is achieved through biological mechanisms including antibody-dependent cellular cytolysis and complement-dependent cytolysis.
Details
- Status
- Prescription
- First Approved
- 2022-12-28
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
BRIUMVI Approval History
What BRIUMVI Treats
3 indicationsBRIUMVI is approved for 3 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Clinically isolated syndrome
- Relapsing-remitting multiple sclerosis
- Active secondary progressive multiple sclerosis
BRIUMVI Target & Pathway
ProTarget
A protein found on the surface of B-cells but not stem cells or plasma cells. Anti-CD20 antibodies deplete B-cells, making them effective in B-cell cancers and autoimmune diseases where B-cells drive pathology.
BRIUMVI Competitors
Pro10 other drugs also target CD20. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CD20). Earlier expiry dates signal biosimilar/generic opportunities.
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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.
BRIUMVI FDA Label Details
ProIndications & Usage
FDA Label (PDF)BRIUMVI is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BRIUMVI is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults .
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.