Sobi’s HLH Drug Recommended for Approval in ChinaFebruary 25, 2022
Sobi has announce that the Center for Drug Evaluation (CDE) has recommended approval of Gamifant to the National Medical Products Administration of China (NMPA). 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.
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 treatment option for patients with progressive disease through a targeted mode of action, the company said.
“We are grateful that CDE has recommended Gamifant as potentially the first approved treatment for primary HLH in China,” said Norbert Oppitz, Head of International at Sobi. “If approved by the NMPA, this will be welcome news for those impacted by primary HLH across China.”