7 April 2022 - Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung function and health-related quality of life for children.
The European Commission has expanded the marketing authorisation for Dupixent (dupilumab) in the European Union.
Dupixent is now also approved in children aged 6 to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fractional exhaled nitric oxide, who are inadequately controlled with medium to high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.