Nexviadyme
Avalglucosidase alfa
Table of contents
Overview
Nexviadyme is an enzyme replacement therapy used to treat patients with Pompe disease, a rare inherited disorder caused by the lack of an enzyme called alpha-glucosidase. Patients with Pompe disease have a build-up of glycogen (complex sugars) in body tissues, including the heart, lung and skeletal muscles, causing enlarged heart, breathing difficulties and muscle weakness.
Nexviadyme contains the active substance avalglucosidase alfa.
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Nexviadyme : EPAR - Medicine overview (PDF/121.67 KB)
First published: 27/07/2022
EMA/429680/2021 -
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Nexviadyme : EPAR - Risk-management-plan summary (PDF/171.15 KB)
First published: 27/07/2022
Authorisation details
Product details | |
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Name |
Nexviadyme
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Agency product number |
EMEA/H/C/005501
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Active substance |
Avalglucosidase alfa
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International non-proprietary name (INN) or common name |
Avalglucosidase alfa
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Therapeutic area (MeSH) |
Glycogen Storage Disease Type II
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Anatomical therapeutic chemical (ATC) code |
A16
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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. |
Publication details | |
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Marketing-authorisation holder |
Sanofi B.V.
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Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
24/06/2022
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Contact address |
Paasheuvelweg 25 |
Product information
24/05/2023 Nexviadyme - EMEA/H/C/005501 - IA/0010/G
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
Nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid α-glucosidase deficiency).
Assessment history
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 202112/11/2021
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17/09/2021
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23/07/2021