Sanofi has secured approval for Dupixent (dupilumab) from the European Commission (EC) to treat 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 such young children.
Dupixent is a fully human monoclonal antibody which blocks the signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.
It has received regulatory approval in many countries for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP), asthma, eosinophilic esophagitis (EoE) and prurigo nodularis in different age groups.
Head of Sanofi Immunology and Inflammation Global Development, Naimish Patel, said: “The vast majority of people with atopic dermatitis begin to develop symptoms during their earliest, most vulnerable years, and these symptoms can often continue throughout 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 patients aged six months to five years.
Dupixent was found to improve skin clearance and reduce overall disease severity and itch compared to a placebo.
In the overall disease population and among those severely affected, the antibody also improved skin pain, sleep quality and quality of life compared to a placebo.
In 2017, Sanofi partnered with the Lebanon, New Hampshire-based ImmuNext to develop an antibody for autoimmune diseases like lupus and multiple sclerosis, which included giving Sanofi a worldwide license to develop frexalimab. The agreement involved milestone payments upto $500 million.
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