Sanofi: EU approves Xenpozyme
(CercleFinance.com) - Sanofi announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a positive opinion and recommended the marketing of Xenpozyme.
The biopharmaceutical company said that this green light relates to the approval of Xenpozyme in the non-neurological manifestations of acid sphingomyelinase type A/B and type B deficiency.
The CHMP opinion is based on the positive results of two clinical trials that demonstrated that Xenpozyme improved respiratory function and reduced spleen and liver volume, with a well-tolerated safety profile.
Xenpozyme is a recombinant human enzyme developed to address the deficiency of acid sphingomyelinase, the enzyme that breaks down the lipid sphingomyelin.
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