The European Commission (EC) has expanded the marketing authorisation for Dupixent – also known as dupilumab – throughout the European Union (EU).
It will be used primarily for 6- to 11-year-old children as an add-on maintenance treatment for severe asthma with type 2 inflammation, characterised by raised blood eosinophils and fractional exhaled nitric oxide. Patients using it will be those inadequately controlled with medium-to-high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
Naimish Patel is head of global development, Immunology and Inflammation at Sanofi, and spoke about bringing the well-established safety and efficacy of Dupixent to an even younger group of patients living with 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,” he said. “This is particularly meaningful as these are medicines that can carry significant safety risks if used long term.”
The EC decision is based on pivotal data from the successful phase 3 Voyage trial. This evaluated the efficacy and safety of Dupixent, combined with standard-of-care asthma therapy, in 408 children with uncontrolled moderate-to-severe asthma.
Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The phase 3 clinical programme – which demonstrated significant clinical benefit and a decrease in type 2 inflammation – has established that IL-4 and IL-13 are central drivers of the inflammation that plays a major role in multiple related diseases.
Asthma currently is one of the most common chronic diseases in infants, with up to 85% of children with the condition suffering some form of type 2 inflammation. Uncontrolled severe asthma can also have negative lifestyle impacts, interfering with day-to-day activities, like sleeping, attending school and playing sports.
George Yancopoulos, president and chief scientific officer at Regeneron, said: “Today’s approval in Europe recognises the benefits of Dupixent in helping children living with the profound effects of severe asthma. Dupixent significantly reduces asthma attacks, helps children breathe better and improves their health-related quality of life.”