BioCentury
ARTICLE | Clinical News

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

November 30, 2018 6:25 PM UTC

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.

The July deal was valued at over SEK4 billion ($451.7 million) (see "Sobi Grabs Emapalumab, Anticipates 2018 Approval")...