20 November 2018 - The U.S. FDA today approved Gamifant (emapalumab) for the treatment of paediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis who have refractory, recurrent or progressive disease or intolerance with conventional hemophagocytic lymphohistiocytosis therapy. 

This FDA approval is the first for a drug specifically for hemophagocytic lymphohistiocytosis.

The FDA granted this application priority review and breakthrough therapy designation. Gamifant also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.Read FDA press release