VUMERITY
VUMERITY (diroximel fumarate) is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. The medication is used to manage specific disease presentations, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It serves as a therapeutic option for adults across these various classifications of relapsing MS.
How VUMERITY Works
The exact mechanism by which diroximel fumarate exerts its therapeutic effect in multiple sclerosis is unknown. Its active metabolite, monomethyl fumarate (MMF), has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, which is involved in the cellular response to oxidative stress. Additionally, MMF has been identified as a nicotinic acid receptor agonist.
Details
- Status
- Prescription
- First Approved
- 2019-10-29
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE
VUMERITY Approval History
What VUMERITY Treats
3 indicationsVUMERITY is approved for 3 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Clinically isolated syndrome
- Relapsing-remitting multiple sclerosis
- Active secondary progressive multiple sclerosis
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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.
VUMERITY FDA Label Details
ProIndications & Usage
FDA Label (PDF)VUMERITY 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. VUMERITY 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.