Posted by Michael Wonder on 21 May 2022
CHMP recommends approval of Xenpozyme (olipudase alfa), the first and only treatment for ASMD
20 May 2022 - Recommendation based on positive results from two clinical trials in which Xenpozyme provided improvement across multiple non-CNS clinical manifestations of ASMD in paediatric and adult patients.
The EMA's CHMP has adopted a positive opinion for Xenpozyme (olipudase alfa), recommending that this investigational enzyme replacement therapy be approved in the European Union for the treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in paediatric and adult patients with ASMD type A/B or ASMD type B.
