Sobi, Novimmune announce US FDA approves Gamifant to treat primary HLH

Swedish Orphan Biovitrum AB (Sobi), an international biopharmaceutical company dedicated to rare diseases, and Novimmune SA, a Swiss biotech company, announced that the US Food and Drug Administration (FDA) has approved Gamifant (emapalumab-lzsg), an interferon gamma (IFN?) blocking antibody for the treatment of paediatric (new born and older) and adult patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy. Primary HLH is an ultra-rare syndrome of hyperinflammation with high morbidity and mortality and for which there was previously no approved drug. Gamifant represents a major advance in the treatment of these patients through a targeted mode of action.