Sanofi: Brussels approves Xenpozyme

(CercleFinance.com) - Sanofi has announced that the European Commission has approved Xenpozyme, for the treatment of non-neurological manifestations of acid sphingomyelinase deficiency in children and adults with type A/B or type B acid sphingomyelinase deficiency.


This approval was based on ASCEND and ASCEND-Peds trials, which showed significant and clinically meaningful improvements in lung function and reductions in spleen and liver volume, with a favourable safety profile.

The European Medicines Agency (EMA) has granted Xenpozyme a Priority Medicinal Product (PRIME) designation and several regulatory authorities around the world have also granted it Innovative Medicines designation.


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