The European Commission (EC) has expanded the marketing authorization for Sanofi’s Dupixent (dupilumab) in the European Union to include treatment of children aged 6 to 11 years as an add-on maintenance treatment for uncontrolled severe asthma.
This is for asthma patients 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, Sanofi explained in its press release.
Naimish Patel, M.D. Head of Global Development, Immunology and Inflammation, Sanofi “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.”
Asthma is one of the most common chronic diseases in children. Up to 85% of children with asthma may have type 2 inflammation and are more likely to have higher disease burden. Despite treatment with current standard-of-care ICS and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing. Severe asthma may impact children’s developing airways and cause potentially life-threatening exacerbations. Children with severe asthma also may require the use of multiple courses of systemic corticosteroids that carry significant risks. Uncontrolled severe asthma can interfere with day-to-day activities, like sleeping, attending school and playing sports.
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent Phase 3 clinical program, which has shown significant clinical benefit and a decrease in type 2 inflammation, has established that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in in multiple related and often co-morbid diseases, the company explained.
George D. Yancopoulos, M.D., Ph.D. President and Chief Scientific Officer, Regeneron “Today’s approval in Europe recognizes the benefits of Dupixent in helping children living with the profound effects of severe asthma, including unpredictable asthma attacks, routine disruption to daily activities and the use of systemic steroids that can impede children’s growth. Dupixent is the only treatment available that specifically blocks two key drivers of type 2 inflammation, IL-4 and IL-13, which our trials show plays a major role in childhood asthma, as well as in related conditions such as chronic rhinosinusitis with nasal polyposis and the often co-morbid condition, atopic dermatitis. In clinical trials, Dupixent significantly reduced asthma attacks, helped children breathe better and improved their health-related quality of life. We also remain committed to investigating Dupixent in other conditions where type 2 inflammation may significantly impact patients’ lives, including eosinophilic esophagitis, prurigo nodularis and chronic spontaneous urticaria.”
The EC decision is based on pivotal data from the Phase 3 VOYAGE trial evaluating the efficacy and safety of Dupixent combined with standard-of-care asthma therapy in 408 children with uncontrolled moderate-to-severe asthma, Sanofi said.