Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (NASDAQ: SNY) have confirmed that European Commission has extended the marketing authorization for Dupixent (dupilumab) in the European Union. Dupixent is now authorized as an add-on maintenance medication for severe asthma with type 2 inflammation in children aged 6 to 11 years.
Presently, one of the most prevalent chronic disorders in children is asthma. Type 2 inflammation affects up to 85% of children with asthma, and they are more likely to have a higher illness severity. These children may continue to have significant symptoms such as coughing, wheezing, and trouble breathing despite therapy with current standard-of-care ICS and bronchodilators.
Dupixent is a completely human monoclonal antibody that suppresses the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. It was developed utilizing Regeneron's unique VelocImmune technology. The EC's decision is based on key findings from the Phase 3 VOYAGE trial, which looked at the efficacy and safety of Dupixent in combination with standard asthma medication in 408 kids with uncontrolled moderate-to-severe asthma.
Dupixent is also approved for treatment in some individuals with asthma, particularly patients with moderate-to-severe atopic dermatitis, and CRSwNP in various age groups in Europe, the United States, Japan, and other countries across the world. Dupixent is also authorized in more than 60 countries for one or more of these indications, with more than 400,000 patients treated worldwide.
Furthermore, the trial's safety findings were broadly consistent with Dupixent's known safety profile in patients aged 12 and up with uncontrolled moderate-to-severe asthma. Dupixent had an overall rate of 83 percent adverse events, while placebo had an overall rate of 80 percent.