Posted by Michael Wonder on 28 Feb 2025
US FDA grants priority review to Sobi's supplemental biologics licence application for Gamifant (emapalumab-lzsg)
27 February 2025 - Sobi today announced that the US FDA has accepted the supplemental biologics license application for Gamifant (emapalumab-Izsg) for use in adult and paediatric patients with hemophagocytic lymphohistiocytosis/macrophage activation syndrome in Still’s disease with an inadequate response or intolerance to glucocorticoids, or with recurrent macrophage activation syndrome.
The application was granted priority review with a PDUFA date of 27 June 2025.
