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− Primary HLH is an ultra-rare syndrome of hyper-inflammation that usually occurs within the first year of life and can rapidly become lethal unless diagnosed and treated –

− To date, primary HLH required immediate induction therapy with steroids and chemotherapy to control hyper-inflammation, followed by hematopoietic stem cell transplant, but mortality remained high –

− FDA approval of Gamifant marks first significant improvement in primary HLH induction therapy in 24 years –

Sobi, an international biopharmaceutical company dedicated to rare diseases, and Novimmune SA, a Swiss biotech company, today announced that the U.S. Food and Drug Administration (FDA) has approved Gamifant® (emapalumab-lzsg), an interferon gamma (IFNγ) blocking antibody for the treatment of pediatric (newborn and older) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy...

11/20/2018 - 9:35