Gamifant FDA Approval History
Last updated by Judith Stewart, BPharm on June 30, 2025.
FDA Approved: Yes (First approved November 20, 2018)
Brand name: Gamifant
Generic name: emapalumab-lzsg
Dosage form: Injection
Company: Sobi Inc.
Treatment for: Hemophagocytic Lymphohistiocytosis, Macrophage Activation Syndrome, Still's Disease
Gamifant (emapalumab-lzsg) is an interferon gamma (IFNγ) blocking antibody for the treatment of primary hemophagocytic lymphohistiocytosis and macrophage activation syndrome in Still’s disease.
- 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 administered by intravenous infusion.
- Warnings and precautions associated with Gamifant include infections and infusion-related reactions.
- Common adverse reactions (≥ 20%):
- in patients with primary HLH include infections, hypertension, infusion-related reactions, and pyrexia.
- in patients with HLH/MAS in Still’s disease include viral infections, including cytomegalovirus infection or reactivation, and rash.
Development timeline for Gamifant
Further information
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