FDA approves emapalumab for hemophagocytic lymphohistiocytosis
- FLASCO
- November 20, 2018
- Drugs
- No Comments
On November 20, 2018, the Food and Drug Administration approved emapalumab (GAMIFANT, Novimmune SA), a monoclonal antibody that binds and neutralizes interferon gamma, for adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Approval was based on a multicenter, open-label,…