Regeneron : Phase 3 Results Show Dupixen Improved Skin Clearance In Children With Atopic Dermatitis

Phase 3 results showed that adding Dupixent or dupilumab to standard-of-care topical corticosteroids significantly improved skin clearance and reduced overall disease severity and itch in infants and children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis, Regeneron Pharmaceuticals Inc. (REGN) and Sanofi said in a statement on Monday.

The companies noted that the data will be presented on Monday in a late-breaking session at the 2021 Revolutionizing Atopic Dermatitis Conference.

The safety profile observed in the randomized, placebo-controlled trial was consistent with the well-established safety profile of Dupixent in adults, adolescents and children 6 years and older with moderate-to-severe atopic dermatitis.

The results will form the basis of global regulatory submissions for the age group, beginning with the U.S. in 2021 and European Union in the first half of 2022.

Additionally, long-term data from the Phase 3 trial in patients aged 6 to 11 years with moderate-to-severe atopic dermatitis are also being presented in a late-breaking session. Efficacy and safety results at one year were consistent with the known profile of Dupixent in atopic dermatitis.

The data from the trials add to the extensive LIBERTY AD clinical program - the largest Phase 3 clinical trial program in atopic dermatitis, involving about 3,500 infants, children, adolescents and adults to date.

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