Emapalumab-Izsg is under the FDA’s Priority Review for hemophagocytic lymphohistiocytosis/macrophage activation syndrome in Still disease.

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

Swedish Orphan Biovitrum AB (Sobi), a specialised international biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License ...

Sobi’s Gamifant was previously approved by the US regulator in 2018. © Swedish Orphan Biovitrum AB. The US Food and Drug Administration has accepted Sobi’s ...

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 ...

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

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

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, ...