Swedish Orphan Biovitrum (STO: SOBI), the Nordic biotech also known as Sobi on Friday announced that the US Food and Drug Administration (FDA) approved Gamifant (emapalumab-lzsg) for a new indication, edging the company’s shares up 2.4% to 284.60 kronor.
Gamifant is now authorized for the treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic juvenile idiopathic arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.
“With our expertise in primary hemophagocytic lymphohistiocytosis, we understand the urgency of managing MAS quickly to improve patient outcomes,” said Guido Oelkers, chief executive Officer at Sobi, adding: “Gamifant is already an established therapy making a meaningful difference for patients with primary HLH, and with this approval, we are excited about the opportunity to positively impact patients affected by MAS in Still’s disease.”
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