BRIEF—EC extends Dupixent use for asthma in younger children

The European Commission (EC) has expanded the marketing authorization for French pharma major Sanofi’s Dupixent (dupilumab) in the European Union.

Dupixent is now also approved in children aged six to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.

Commenting on the approval Dr Naimish Patel, head of global development, immunology and inflammation at Sanofi, said: “We are excited to bring the well-established safety and efficacy of Dupixent to even younger patients living with uncontrolled severe asthma in Europe. In addition to greatly reducing severe asthma attacks and improving lung function, patients in our clinical trial also reduced their oral corticosteroid use.

“This is particularly meaningful as these are medicines that can carry significant safety risks if used long term. This approval underscores our continued commitment to bringing Dupixent to as many patients as possible suffering from the negative effects of severe asthma with the hope of improving their quality of life.”