Dupixent
dupilumab
Table of contents
Overview
Dupixent is a medicine used to treat patients aged 12 years or over with moderate to severe atopic dermatitis (also known as atopic eczema, when the skin is itchy, red and dry) when treatments applied to the skin are not sufficient or appropriate. Patients from 6 up to 12 years of age can also be given the medicine if their condition is severe.
Dupixent may be added to maintenance treatment for severe asthma in patients aged 6 years or more, whose asthma is not properly controlled by appropriate combination therapy (high-dose corticosteroids over 12 years of age, medium-to-high dose in those younger, taken by inhalation, plus another medicine used for the prevention of asthma). Dupixent is only for use in patients with a type of inflammation of the airways called ‘type 2 inflammation’.
Dupixent can also be added to local treatment with corticosteroids for adults who have inflammation of the nose and sinuses together with growths (polyps) obstructing the airways in the nose (chronic rhinosinusitis with nasal polyposis). It is used when other treatments have not worked well enough.
Dupixent contains the active substance dupilumab.
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List item
Dupixent : EPAR - Summary for the public (PDF/103.56 KB)
First published: 11/10/2017
Last updated: 08/04/2022
EMA/109369/2022 -
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List item
Dupixent : EPAR - Risk-management-plan summary (PDF/148.52 KB) (updated)
First published: 28/06/2019
Last updated: 28/02/2023
Authorisation details
Product details | |
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Name |
Dupixent
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Agency product number |
EMEA/H/C/004390
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Active substance |
dupilumab
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International non-proprietary name (INN) or common name |
dupilumab
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
D11AH05
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Publication details | |
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Marketing-authorisation holder |
Sanofi Winthrop Industrie
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Revision |
24
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Date of issue of marketing authorisation valid throughout the European Union |
26/09/2017
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Contact address |
82 avenue Raspail |
Product information
23/01/2023 Dupixent - EMEA/H/C/004390 - II/0062
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
Therapeutic indication
Dupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
Atopic dermatitis
Adults and adolescents
Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
Children 6 to 11 years of age
Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 to 11 years old who are candidates for systemic therapy.
Asthma
Adults and adolescents
Dupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
Children 6 to 11 years of age
Dupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
Atopic dermatitis
Adults and adolescents
Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
Children 6 to 11 years of age
Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 to 11 years old who are candidates for systemic therapy.
Chronic rhinosinusitis with nasal polyposis
(CRSwNP)
Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
Prurigo Nodularis (PN)
Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
Eosinophilic esophagitis (EoE)
Dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy (see section 5.1).
Assessment history
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 202327/01/2023
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16/12/2022
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 202211/11/2022
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 January 202228/01/2022
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 202016/10/2020
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20/09/2019
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28/06/2019
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01/03/2019
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01/03/2019
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21/07/2017