Xenpozyme
For information on Xenpozyme, approved for the treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients, visit XENPOZYME® (olipudase alfa-rpcp)
Latest News
U.S. FDA approves Xenpozyme™ (olipudase alfa) for treatment of ASMD
We are pleased to share the U.S. Food and Drug Administration (FDA) has approved Xenpozyme™ (olipudase alfa-rpcp) for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients! Xenpozyme is the first therapy indicated specifically for the treatment of ASMD, and is currently the only approved treatment for this disease.
This has been a long road and the ASMD community played a vital and persistent role in bringing this medicine through the trials process and to an approval. We are incredibly pleased that we now have a first approved medicine in the Niemann-Pick community.
Read Sanofi press release.
Read FDA press release.
Read Xenpozyme press release.
08/31/2022
European Approval! News from Sanofi on Xenpozyme (olipudase alfa)
We are thrilled to share this exciting news! Sanofi released the following news today: “Xenpozyme® (olipudase alfa) approved by European Commission as first and only treatment for ASMD”. The European Commission (EC) has approved Xenpozyme® (olipudase alfa) as the first and only enzyme replacement therapy for the treatment of non-Central Nervous System (CNS) manifestations of Acid Sphingomyelinase Deficiency (ASMD) in pediatric and adult patients with ASMD type A/B or ASMD type B. We will continue to update you as information becomes available.