Basic Information
Dupixent
Regulatory Information
EMEA/H/C/004390
September 26, 2017
July 20, 2017
42
April 30, 2025
Company Information
France
82 Avenue Raspail 94250 Gentilly
SANOFI WINTHROP INDUSTRIE
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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), 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. 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.
Overview Summary
Dupixent is a medicine used to treat: - moderate to severe atopic dermatitis (also known as atopic eczema, when the skin is itchy, red and dry) in patients aged 12 years and over when topical treatments (treatments applied to the skin) are not sufficient or appropriate. Patients from 6 months up to 12 years of age can also be given the medicine if their condition is severe; - severe asthma in patients aged 6 years and over whose asthma is not properly controlled by appropriate combination therapy (corticosteroids taken by inhalation plus another medicine used for the prevention of asthma). Dupixent is added to maintenance treatment and is only for use in patients with a type of inflammation of the airways called ‘type 2 inflammation’; - chronic obstructive pulmonary disease (COPD), a long-term disease that causes breathing difficulties due to airway obstruction and damage to the lungs. Dupixent is used in adults who have increased levels of eosinophils (a type of white blood cell) and whose disease is not controlled well enough with a combination of a long-acting beta-2 agonist, a long-acting muscarinic agonist and an inhaled corticosteroid (other COPD medicines), or a combination of the first two if an inhaled corticosteroid is not appropriate. It is used with other medicines as maintenance (regular) treatment; - inflammation of the nose and sinuses together with growths (polyps) obstructing the airways in the nose (chronic rhinosinusitis with nasal polyposis). It is used in adults in addition to local treatment with corticosteroids when other treatments have not worked well enough; - moderate-to-severe prurigo nodularis (a long-term skin disease with a rash causing lumps with intense itching) in adults. It is used with or without topical (applied to the skin) corticosteroids; - eosinophilic oesophagitis (an allergic inflammatory condition of the foodpipe) in adults and children from 1 year of age and weighing at least 15 kg, who cannot take conventional treatment or for whom it is not working. Dupixent contains the active substance dupilumab.