Sanofi: Xenpozyme approved in Europe

Posted 28 June, 2022

The European Commission (EC) has approved Sanofi's Xenpozyme (olipudase alfa), the first and only enzyme replacement therapy indicated for the treatment of non-neurological manifestations of acid sphingomyelinase deficiency in children and adults with acid sphingomyelinase deficiency type A/B or type B.

This approval is based on positive data from clinical trials in which Xenpozyme demonstrated significant and clinically meaningful improvements in respiratory function (as measured by the predicted carbon loss or DLCO), as well as a reduction in the volume of the spleen and liver, with a favorable safety profile.

Recognizing the urgent unmet medical needs of patients with acid sphingomyelinase deficiency, the European Medicines Agency (EMA) has granted Xenpozyme Priority Medicines (PRIME) designation. Several regulatory bodies around the world have also given it the designation of "innovative medicine".

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28 June, 2022 09:42

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