Sobi files MAA in China for emapalumab for treatment of adult and paediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis.

Swedish Orphan Biovitrum AB (publ) (Sobi) announced that a Marketing Authorization Application for emapalumab has been accepted for review in China. The targeted indication is for treatment of adult and paediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Primary HLH is a rare syndrome that typically presents in infancy but can also be seen in adults and is associated with high morbidity and mortality. In spite of some treatment advances, there continues to be a very high unmet medical need in particular in patients that have failed conventional therapy as there are no approved treatment options outside the US. In the US, emapalumab is the first therapy approved by the FDA for primary HLH. Over 100 patients have been treated in the US and the benefit/risk profile continues to be favourable..