OCREVUS
Ocrevus (ocrelizumab) is a CD20-directed cytolytic antibody indicated for the treatment of multiple sclerosis in adult patients. The medication is used to manage relapsing forms of the disease, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It is also approved for the treatment of primary progressive multiple sclerosis.
How OCREVUS Works
Ocrelizumab functions by binding to CD20, a cell surface antigen found on pre-B and mature B lymphocytes. While the precise therapeutic mechanism in multiple sclerosis is unknown, this binding leads to the destruction of these B cells. The process occurs through antibody-dependent cellular cytolysis and complement-mediated lysis.
Details
- Status
- Prescription
- First Approved
- 2017-03-28
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
OCREVUS Approval History
What OCREVUS Treats
2 indicationsOCREVUS is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease)
- Primary progressive multiple sclerosis
OCREVUS 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.
OCREVUS 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.
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.
OCREVUS FDA Label Details
ProIndications & Usage
FDA Label (PDF)OCREVUS 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 Primary progressive MS, in adults OCREVUS 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 Primary progressive MS, in adults
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.