Emapalumab submission in China for primary HLH accepted

10 December 2020

Rare diseases specialist Swedish Orphan Biovitrum (STO: SOBI), also known as Sobi, today announced that a Marketing Authorization Application for emapalumab has been accepted for review in China.

The targeted indication is for treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.

“Today’s announcement marks an important step for those affected by primary HLH, as currently there are no approved treatments available in China to meet the vast unmet medical need for this life-threatening condition,” said Ravi Rao, head of R&D and chief medical officer at Sobi.

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