10:25 AM
Nov 30, 2018
 |  BC Week In Review  |  Clinical News  |  Regulatory

On heels of Sobi deal, Novimmune's emapalumab gets FDA approval

FDA approved Gamifant emapalumab-lzsg from Novimmune S.A. (Plan-les-Ouates, Switzerland), giving Novimmune a Priority Review voucher and the first U.S.-approved drug for hemophagocytic lymphohistiocytosis (HLH). Novimmune said it plans to sell the Priority Review voucher. The approval comes just four months after Swedish Orphan Biovitrum AB (SSE:SOBI) gained exclusive, worldwide rights to Gamifant in a deal which stipulated that Sobi cover all development and commercialization costs beginning in September.

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