GLATOPA
Glatopa (glatiramer acetate) is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. The medication is used to manage various stages of the disease, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It serves a therapeutic role by targeting the immune processes believed to be responsible for the pathogenesis of MS.
How GLATOPA Works
While the exact mechanism of glatiramer acetate is not fully understood, it is thought to act by modifying immune processes associated with the development of multiple sclerosis. Research suggests that the drug induces and activates specific suppressor T-cells within the peripheral immune system. These activated cells are believed to influence the immune responses that contribute to the damage of the central nervous system.
Details
- Status
- Prescription
- First Approved
- 2015-04-16
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
GLATOPA Approval History
What GLATOPA Treats
3 indicationsGLATOPA is approved for 3 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Clinically isolated syndrome
- Relapsing-remitting disease
- Active secondary progressive disease
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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.
GLATOPA FDA Label Details
ProIndications & Usage
FDA Label (PDF)Glatopa 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. Glatopa 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 .
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.