FDA priority review for Sobi’s Gamifant sBLA

The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gamifant (emapalumab-Izsg), submitted by Swedish Orphan Biovitrum (STO: SOBI), the Nordic biotech also known as Sobi.

The sBLA is for use of Gamifant in adult and pediatric patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in Still’s disease with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. The application was granted Priority Review with a PDUFA date of June 27, 2025.

The global Still's Disease Treatment Market size was valued at $1.83 billion in 2023 and is expected to reach $2.55 billion in 2030.