Rare EU Fast-Track Nod For Sanofi Genzyme's Olipudase Alfa

Product Is One Of Few To Secure Accelerated Assessment In Recent Months

Only three planned marketing authorization applications are known to have been granted accelerated assessment status by the European Medicines Agency between July and October this year. 

Winners or Losers - Traffic sign with two options
More EU fast-track requests get rejected than accepted • Source: Alamy

The EU marketing authorization application (MAA) for Sanofi Genzyme's olipudase alfa will be reviewed under the European Medicines Agency's accelerated assessment mechanism when the company files for approval.

Olipudase alfa is a potential therapy for the long-term treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick disease Type B

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