Sobi has announced that the National Medical Products Administration of China (NMPA) has approved Gamifant (emapalumab) for use in China. The indication is for treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy. The approval followed the recommendation announced in February 2022.
Primary HLH is an ultra-rare, life-threatening, hyperinflammatory disorder, characterised by uncontrolled activation of the immune system. Morbidity and mortality are high due to lack of detection and non-specific symptoms, but if diagnosed early and appropriately treated, the inflammation and damage can be reduced. Gamifant represents a new treatment option for patients with progressive disease through a targeted mode of action, Sobi said in a press release..
“We are very pleased to announce the approval by the NMPA of this important treatment for patients with primary HLH in China. We look forward to serving those affected by this very serious and severe condition in China,” said Norbert Oppitz, Head of International at Sobi.