Category: Asia

Xenpozyme (olipudase alfa) Approved in Japan, First and Only Approved Therapy Indicated to Treat Acid Sphingomyelinase Deficiency
March 28, 2022 Off

Xenpozyme (olipudase alfa) Approved in Japan, First and Only Approved Therapy Indicated to Treat Acid Sphingomyelinase Deficiency

By Dino Mustafić

The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for Xenpozyme (olipudase alfa) for the treatment of adult and pediatric patients with non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare, progressive, and potentially life-threatening genetic disease.

Gamifant Approved in China for the Treatment of Primary HLH
March 18, 2022 Off

Gamifant Approved in China for the Treatment of Primary HLH

By Dino Mustafić

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.