fda-approval-letter
PHARMACY

FDA approves Gamifant for ultra-rare illness

BY Sandra Levy

Sobi, an international biopharmaceutical company dedicated to rare diseases, and Novimmune, a Swiss biotech company, have received the green light from the Food and Drug Administration for Gamifan (emapalumab-lzsg), an interferon gamma, blocking antibody for the treatment of pediatric — newborn and older — and adult patients with primary hemophagocytic lymphohistiocytosis, or HLH, with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy.

Primary HLH is an ultra-rare syndrome of hyper-inflammation with high morbidity and mortality, and for which there was previously no approved drug. Gamifant represents a major advance in the treatment of these patients through a targeted mode of action.

“Today’s landmark approval of Gamifant will allow Sobi to bring the first and only FDA-approved treatment for primary HLH to a rare disease community that has faced high mortality without much improvement in care for the past 24 years,” Sobi North America president Rami Levin said.

Gamifant is expected to be available for administration in treatment centers in the first quarter of 2019.

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