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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.

Development timeline for Gamifant

DateArticle
Jun 28, 2025Approval FDA Approves Gamifant (emapalumab-lzsg) as First-Ever Treatment for Adults and Children with Macrophage Activation Syndrome in Still's Disease
Nov 20, 2018Approval FDA Approves Gamifant (emapalumab-lzsg) for Primary Hemophagocytic Lymphohistiocytosis

Further information

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