CHMP recommends approval of dupixent for children with severe asthma

pharmafile | January 31, 2022 | News story | Sales and Marketing  

The EMA’s CHMP has adopted a positive opinion recommending the extension of the approval of Dupixent (dupilumab) for children with severe asthma. The treatment is recommended as an add-on maintenance treatment for children aged 6 to 11 years with severe asthma, with type 2 inflammation characterised by raised blood eosinophils.

The EC is expected to announce a final decision on the Dupixent application in the coming months.

The CHMP positive opinion is supported by Phase III data recently published in the New England Journal of Medicine, illustrating that Dupixent, alongside standard of care, significantly reduced the rate of severe asthma attacks and rapidly improved lung function within two weeks, with sustained improvement up to 52 weeks, in children with uncontrolled moderate-to-severe asthma.

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 a higher disease burden. Despite treatment with current standard-of-care inhaled corticosteroids (ICS) and bronchodilators, these children could still experience serious symptoms such as coughing, wheezing, and difficulty breathing.

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. IL-4 and IL-13 are important drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis. The treatment is currently approved in Europe for certain adults and adolescents with asthma 12 years and older. It is also approved in over 60 countries around the world, and more than 350,000 patients have been treated globally.

Lina Adams

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