Xenpozyme
olipudase alfa
Table of contents
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.
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Xenpozyme : EPAR - Medicine overview (PDF/113.1 KB)
First published: 27/07/2022
EMA/329151/2022 -
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Xenpozyme : EPAR - Risk-management-plan summary (PDF/155.97 KB)
First published: 27/07/2022
Authorisation details
Product details | |
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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 |
A16AB25
|
Additional 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. |
Orphan |
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 | |
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Marketing-authorisation holder |
Sanofi B.V.
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Revision |
1
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Date of issue of marketing authorisation valid throughout the European Union |
24/06/2022
|
Contact address |
Paasheuvelweg 25 |
Product information
21/04/2023 Xenpozyme - EMEA/H/C/004850 - IAIN/0004
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.