GAMIFANT
Gamifant (emapalumab-lzsg) is an interferon gamma blocking antibody indicated for the treatment of primary hemophagocytic lymphohistiocytosis (HLH) in adult and pediatric patients, including newborns. It is used in cases where the disease is refractory, recurrent, or progressive, or when patients are intolerant to conventional HLH therapy. The medication is also approved for patients with HLH/macrophage activation syndrome (MAS) related to Still’s disease who show an inadequate response to glucocorticoids or have recurrent MAS.
How GAMIFANT Works
Emapalumab-lzsg functions as a monoclonal antibody that targets and neutralizes interferon gamma (IFNγ). This specific protein is hypersecreted in patients with hemophagocytic lymphohistiocytosis (HLH), contributing to the pathogenesis of the disease. By binding to IFNγ, the drug inhibits its biological activity to treat the condition.
Details
- Status
- Prescription
- First Approved
- 2018-11-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
GAMIFANT Approval History
What GAMIFANT Treats
4 indicationsGAMIFANT is approved for 4 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hemophagocytic Lymphohistiocytosis
- Macrophage Activation Syndrome
- Still's Disease
- Systemic Juvenile Idiopathic Arthritis
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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.
GAMIFANT FDA Label Details
ProIndications & Usage
FDA Label (PDF)GAMIFANT is indicated for the treatment of: adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. adult and pediatric ( newborn and older) patients with HLH/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. GAMIFANT is an interferon gamma (IFNγ) neutralizing antibody indicated for the ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.