Posted by Michael Wonder on 08 May 2019
Dupixent (dupilumab) approved for severe asthma by European Commission
7 May 2019 - Only biologic approved in the European Union for severe asthma with type 2 inflammation, as characterised by raised blood eosinophils and/or raised fractional exhaled nitric oxide.
The European Commission has approved Dupixent (dupilumab) for use in adults and adolescents 12 years and older 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 high dose inhaled corticosteroid plus another medicinal product for maintenance treatment.
The approval is based on clinical data from 2,888 adults and adolescents who participated in three pivotal trials from the global LIBERTY ASTHMA program, including the Phase 3 QUEST and VENTURE trials and a Phase 2b trial.
