Xenpozyme

RSS

olipudase alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

Xenpozyme is a medicine for treating patients with acid sphingomyelinase deficiency (ASMD), a genetic condition, historically known as Niemann-Pick disease type A, A/B and B. There are three types of Niemann-Pick disease (A, B and C), with different genetic causes and different symptoms. Xenpozyme is used to treat patients with type A/B or type B. It is intended to treat the symptoms of ASMD that are not related to the brain.

Niemann-Pick disease is rare, and Xenpozyme was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 5 December 2016. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu-3-01-056.

Xenpozyme contains the active substance olipudase alfa.

This EPAR was last updated on 27/07/2022

Authorisation details

Product details
Name
Xenpozyme
Agency product number
EMEA/H/C/004850
Active substance
Olipudase alfa
International non-proprietary name (INN) or common name
olipudase alfa
Therapeutic area (MeSH)
Acid sphingomyelinase deficiency (ASMD) type A/B or type B
Anatomical therapeutic chemical (ATC) code
A16AB
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Genzyme Europe BV
Date of issue of marketing authorisation valid throughout the European Union
24/06/2022
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
Netherlands

Product information

24/06/2022 Xenpozyme - EMEA/H/C/004850 -

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Xenpozyme is indicated as an enzyme replacement therapy for the treatment of non-Central Nervous System (CNS) manifestations of Acid Sphingomyelinase Deficiency (ASMD) in paediatric and adult patients with type A/B or type B.

Assessment history

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