Emapalumab-Izsg (hereafter referred to as emapalumab) [Gamifant®] is a 
monoclonal antibody directed against interferon gamma that is available as an 
intravenous infusion. Emapalumab is being developed by Novimmune and Swedish 
Orphan Biovitrum for the treatment of haemophagocytic lymphohistiocytosis (HLH). 
In November 2018, emapalumab received its first global approval in the USA, for 
the treatment of paediatric (newborn and older) and adult patients with primary 
HLH, who have refractory, recurrent or progressive disease or intolerance to 
conventional HLH therapy. Emapalumab is under regulatory review in the EU for 
the treatment of primary HLH. This article summarizes the milestones in the 
development of emapalumab leading to this first global approval for HLH in the 
USA.