Swiss-Swedish pairing get FDA nod for rare immune disease drug

The US Food and Drug Administration (FDA) has approved Gamifant (emapalumab-lzsg), an interferon gamma (IFNγ) blocking antibody, in an ultra-rare syndrome of hyperinflammation with high morbidity and mortality and for which there was previously no drug on the market.

Gamifant has been approved for pediatric and adult patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy.

The approval has been granted to privately-held Swiss biotech Novimmune and Swedish Orphan Biovitrum (STO: SOBI), with the latter acquiring the global rights to Gamifant in July of this year through an exclusive licensing agreement.