The sponsors of 11 medicines should learn this week whether the European Medicines Agency will recommend that their products be granted pan-EU marketing authorization. They include Sanofi for its drug olipudase alfa, for treating the rare, progressive, and potentially life-threatening genetic disease, acid sphingomyelinase deficiency (ASMD).
Olipudase alfa, an enzyme replacement therapy for adult and pediatric patients with non-central nervous system manifestations of ASMD, became the world’s first drug to be approved for the condition when it was authorized in Japan in March, under the brand name Xenpozyme. A decision on the US marketing application for the product is expected in early Q3 2022
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