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# Gamifant OK’d for Hemophagocytic Lymphohistiocytosis
- URL: https://www.fdaweb.com/gamifant-okd-for-hemophagocytic-lymphohistiocytosis/
- Published: 2018-11-20T12:00:00.000Z
- Updated: 2026-09-15T00:45:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142859

FDA has approved Novimmune’s Gamifant (emapalumab) for treating pediatric and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional therapy. HLH is a condition in which the body’s immune cells do not work properly, according to an [FDA release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626263.htm?ref=fdaweb.com). The cells become overactive, releasing molecules that lead to inflammation. The immune cells start to damage body organs, including the liver, brain and bone marrow, it says.

Efficacy was demonstrated in a clinical trial involving 27 pediatric patients with suspected or confirmed primary HLH with either refractory, recurrent or progressive disease during conventional HLH therapy or who were intolerant of conventional HLH therapy. The study showed that 63% of patients experienced a response and 70% were able to proceed to stem cell transplant.

Common side effects reported by patients included infections, hypertension, infusion-related reactions, low potassium and fever.