Shots:
- The US FDA has approved Gamifant (emapalumab-lzsg) for treating hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), in pts of all ages who are unresponsive, intolerant to glucocorticoids, or have recurrent MAS
- Approval was based on pooled data from two pivotal trials, P-III (EMERALD) and P-II (NI-0501-06), where 54%(21/39) of pts achieved CR and 82% (32/39) reached MAS remission (VAS ≤1 cm) at Wk 8. Safety was consistent with prior studies
- Gamifant is an IFNγ-blocking mAb that neutralizes excess IFNγ to reduce hyperinflammation. It is administered via a one-hour IV
Ref: PRnewswire | Image: Sobi | Press Release
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