Just months after Swedish Orphan Biovitrum AB (Sobi) acquired global rights to emapalumab from Swiss developer Novimmune SA in a CHF450 million (US$453 million) deal, the companies have won an on-time FDA approval for the ultra-rare disease therapy. Branded as Gamifant, Sobi will market it for the treatment of pediatric and adult patients with the life-threatening inflammatory condition primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance to conventional therapies. It's the first and only FDA-approved therapy for the indication.