Sanofi has secured approval for Dupixent (dupilumab) from the European Commission (EC) for the treatment of severe atopic dermatitis in children aged six months to five years, who are systemic therapy candidates, in the European Union (EU).
This approval makes Dupixent the first and only medicine available in the US and Europe for the treatment of these young children.
The fully human monoclonal antibody Dupixent blocks the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways signalling.
It has also received regulatory approvals in many countries to treat chronic rhinosinusitis with nasal polyposis (CRSwNP), asthma, eosinophilic esophagitis (EoE) or prurigo nodularis in different age groups.
Sanofi Immunology and Inflammation Global Development head Naimish Patel said: “A vast majority of people with atopic dermatitis begin to develop symptoms during their earliest, most vulnerable years, and these symptoms can often continue through the rest of their lives.
“With this latest approval, Dupixent is the first-ever biologic medicine for people living with atopic dermatitis from infancy to adulthood.
“Given its well-established safety and efficacy profile, Dupixent has the potential to transform the landscape for people of all ages living with atopic dermatitis.”
The regulatory approval is based on the data obtained from a Phase III trial.
The placebo-controlled, randomised, double-blind trial assessed the safety and efficacy of Dupixent along with standard-of-care low-potency topical corticosteroids (TCS) compared to low-potency TCS alone (placebo) in 162 moderate-to-severe atopic dermatitis children aged six months to five years.
According to the findings, Dupixent was found to improve skin clearance and reduce overall disease severity and itch compared to placebo.
In the overall and severe populations, the antibody also improved skin pain, sleep quality, and quality of life related to health against placebo.
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