NIKTIMVO (axatilimab-csfr) · INCYTE CORP
NIKTIMVO (axatilimab-csfr) is a colony stimulating factor-1 receptor (CSF-1R) blocker indicated for the treatment of chronic graft-versus-host disease (cGVHD). It is specifically approved for use in adult and pediatric patients weighing at least 40 kg who have failed at least two prior lines of systemic therapy. This medication provides a therapeutic option for patients whose condition has not responded to previous systemic treatments.
How NIKTIMVO Works
Axatilimab-csfr is a monoclonal antibody that binds to colony stimulating factor-1 receptors (CSF-1R) found on monocytes and macrophages. By blocking these receptors, the drug reduces the levels of circulating proinflammatory and profibrotic monocytes and monocyte-derived macrophages. This action inhibits the activity of pathogenic macrophages in tissues, addressing the biological drivers of the disease.
Details
- Status
- Prescription
- First Approved
- 2024-08-14
- Patent Cliff
- 2031
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
NIKTIMVO Approval History
What NIKTIMVO Treats
1 indicationsNIKTIMVO is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Graft-versus-Host Disease
NIKTIMVO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
INCYTE CORP's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
NIKTIMVO FDA Label Details
Indications & Usage
FDA Label (PDF)NIKTIMVO is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. NIKTIMVO is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.