Gamifant from Sobi, Inc. is an interferon gamma (IFNγ) blocking antibody that is FDA-indication to treat adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH). The indication covers refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.
First approved in the U.S. in 2018, Gamifant has run into regulatory roadblocks in Europe. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has twice issued negative opinions related to the drug.
Filed Under: Immunology