Posted by Michael Wonder on 28 Jun 2025
FDA approves Gamifant (emapalumab-lzsg) as first-ever treatment for adults and children with Macrophage Activation Syndrome in Still's disease
28 June 2025 - Approval based on the pooled analysis of our pivotal EMERALD and NI-0501-06 studies, showing 54% of patients treated with Gamifant achieved complete response at week 8.
Sobi today announced that the US FDA approved Gamifant (emapalumab-lzsg) for the treatment of adult and paediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic juvenile idiopathic arthritis, with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.
