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Dupixent has been approved by the EC for children aged 6 to 11 years with severe asthma with type 2 inflammation.
The European Commission (EC) has expanded the marketing authorization for Dupixent in the European Union (EU) as an add-on maintenance treatment of severe asthma with type 2 inflammation in children aged 6 to 11.
Severe asthma with type 2 inflammation is characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide. Dupixent is meant to be used when symptoms are inadequately controlled with medium to high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
Asthma is one of the most common chronic diseases in children, with up to 85% having type 2 inflammation. Serious symptoms such as coughing, wheezing, and difficulty breathing can be experienced, and these symptoms can interfere with everyday activities and quality of life.
“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,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, in a press release. “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.”