The US Food and Drug Administration has accepted Sobi’s supplemental biologics licence application for Gamifant (emapalumab-Izsg) for haemophagocytic lymphohistiocytosis (HLH)/macrophage activation ...

The biologic was approved in 2018 under the brand name Gamifant ® for the the treatment of adult and pediatric (newborn and older) patients with primary HLH with refractory, recurrent or progressive ...

US FDA grants priority review to Sobi’s sBLA for Gamifant for use in adult and paediatric patients with HLH/MAS in Still’s disease: Stockholm Friday, February 28, 2025, 09:00 ...

"There is no approved therapy for HLH/MAS today. Gamifant® (emapalumab-Izsg) selectively neutralizes interferon gamma (IFN-γ), a key driver of hyperinflammation, and if approved, may also help ...

In July 2019, Novimmune divested Gamifant and related activities, and rebranded as Light Chain Bioscience with a focus on bispecific antibodies. Light Chain, which draws on decades of experience ...

STOCKHOLM, Feb. 27, 2025 /PRNewswire/ -- Sobi® (STO: SOBI), today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for ...

HLH/MAS in Still's disease is a serious and potentially fatal complication where patients can experience intense hyperinflammation and even multiple organ failure, said Lydia Abad-Franch, MD, MBA, ...