Posted by Michael Wonder on 31 Jan 2022
CHMP recommends approval of Dupixent (dupilumab) for children aged 6 to 11 years with severe asthma with type 2 inflammation
31 January 2022 - Recommendation based on pivotal trial that showed Dupixent significantly reduced severe asthma attacks and improved lung function in children aged 6 to 11.
The European Medicines Agency's CHMP has adopted a positive opinion recommending to extend the approval of Dupixent (dupilumab) in the European Union to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fractional exhaled nitric oxide who are inadequately controlled on two maintenance therapies.
