KESIMPTA
Kesimpta (ofatumumab) is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. The therapy is approved for use in patients with clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It serves as a targeted therapeutic option for adult patients managing these specific classifications of relapsing MS.
How KESIMPTA Works
Ofatumumab binds to CD20, a cell surface antigen found on pre-B and mature B lymphocytes. While the precise therapeutic mechanism in multiple sclerosis is unknown, the drug is presumed to exert its effects by binding to these specific B cells. This binding results in antibody-dependent cellular cytolysis and complement-mediated lysis, leading to the destruction of the targeted lymphocytes.
Details
- Status
- Prescription
- First Approved
- 2009-10-26
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
KESIMPTA Approval History
What KESIMPTA Treats
3 indicationsKESIMPTA is approved for 3 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Clinically isolated syndrome
- Relapsing-remitting multiple sclerosis
- Active secondary progressive multiple sclerosis
KESIMPTA 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.
KESIMPTA 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.
KESIMPTA FDA Label Details
ProIndications & Usage
FDA Label (PDF)KESIMPTA 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. KESIMPTA 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.