The EC approval is based on pivotal findings from the double-blind, randomised, placebo-controlled Phase III VOYAGE clinical trial of Dupixent
Regeneron Pharmaceuticals headquarters under construction, 2014. (Credit: Jim.henderson/Wikipedia)
The European Commission (EC) has expanded the marketing authorisation for Sanofi and Regeneron’s Dupixent (adupilumab) to include as an add-on maintenance treatment for severe asthma with type 2 inflammation in children aged six to 11 years.
Dupixent is indicated for such patients with type 2 inflammation characterised by increased blood eosinophils and/or elevated fractional exhaled nitric oxide (FeNO).
It can be given to children who are not controlled well following treatment with medium to high dose inhaled corticosteroids (ICS) plus another therapy as maintenance treatment.
A fully human monoclonal antibody, Dupixent is not an immunosuppressant and hinders the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.
The latest expanded approval is based on pivotal findings from the double-blind, randomised, placebo-controlled Phase III VOYAGE clinical trial.
It is designed to evaluate the safety and efficacy of Dupixent plus standard-of-care asthma treatment in 408 children with uncontrolled moderate-to-severe asthma.
The study revealed that Dupixent substantially reduced severe asthma attacks, improved lung function and the health-associated quality of life in children.
In addition, the safety data from the study was in line with the already known safety profile of the antibody in individuals aged 12 years and above with uncontrolled moderate-to-severe asthma.
Sanofi immunology and inflammation global development head Naimish Patel 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.”
In late 2020, Dupixent received EC approval to include treatment of severe atopic dermatitis in children aged between six and 11 years, who are eligible for systemic therapy.