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  1. Home
  2. Medicines
  3. Dupixent - opinion on variation to marketing authorisation

Dupixent - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

dupilumab
Post-authorisation Human

Page contents

  • Opinion
  • Key facts
  • News on Dupixent
  • More information on Dupixent

Opinion

On 18 September 2025 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Dupixent. The marketing authorisation holder for this medicinal product is Sanofi Winthrop Industrie.

The CHMP adopted a new indication as follows1:

Chronic Spontaneous Urticaria (CSU)

Dupixent is indicated for the treatment of moderate to severe chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamines and who are naive to anti-IgE therapy for CSU.

For information, the full indications for Dupixent will be as follows:

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 months to 11 years of age
Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 months 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), see section 5.1, 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), see section 5.1, who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.

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, adolescents and children aged 1 year and older, weighing at least 15 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy (see section 5.1).

Chronic obstructive pulmonary disease (COPD)

Dupixent is indicated in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate (see Section 5.1).

Chronic Spontaneous Urticaria (CSU)

Dupixent is indicated for the treatment of moderate to severe chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamines and who are naive to anti-IgE therapy for CSU.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1New text in bold

CHMP post-authorisation summary of positive opinion for Dupixent (EMA/VR/0000257461)

Adopted Reference Number: EMADOC-1700519818-2222939

English (EN) (159.38 KB - PDF)

First published: 19/09/2025
View

Key facts

Name of medicine
Dupixent
EMA product number
EMEA/H/C/004390
Active substance
dupilumab
International non-proprietary name (INN) or common name
dupilumab
Therapeutic area (MeSH)
  • Dermatitis, Atopic
  • Prurigo
  • Esophageal Diseases
  • Asthma
  • Sinusitis
Anatomical therapeutical chemical (ATC) code
D11AH05
Marketing authorisation holder
Sanofi Winthrop Industrie
Date of opinion
18/09/2025
Status
Positive

News on Dupixent

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025
19/09/2025
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2025
28/02/2025
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2024
20/09/2024
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024
31/05/2024
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023
27/01/2023
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022
16/12/2022
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022
11/11/2022
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 January 2022
28/01/2022
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2020
16/10/2020
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2019
20/09/2019
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2019
28/06/2019
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 February 2019
01/03/2019
New add-on treatment for patients with severe asthma
01/03/2019
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017
21/07/2017

More information on Dupixent

  • Dupixent
This page was last updated on 19/09/2025

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