FDA approves Dupixent as first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis.
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has approved Dupixent (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Regulatory filings for this age group are underway by the European Medicines Agency and regulatory authorities in additional countries.
"Moderate-to-severe atopic dermatitis in babies and young children is more than just a rash – the intense itch can make them scratch uncontrollably throughout the day and night and cause their skin to crack and bleed," said Julie Block, President and Chief Executive Officer at National Eczema Association. "Caregivers do their best to manage skincare routines multiple times a day, but for many, topical treatments are not enough. We're pleased to see how scientific innovation and research continues to address unmet needs for the atopic dermatitis community, and we're hopeful for the positive impact Dupixent can have for these children and their families."
The approval is based on data that include a Phase III trial evaluating Dupixent every four weeks (200 mg or 300 mg, based on body weight) plus low-potency topical corticosteroids (TCS) or TCS alone. The trial met the primary and all secondary endpoints. At 16 weeks, patients who received Dupixent with TCS experienced the following, compared to TCS alone (placebo): i. 28% achieved clear or almost-clear skin compared to 4% with placebo, the primary endpoint. ii. 53% achieved 75% or greater improvement in overall disease severity from baseline compared to 11% with placebo, the co-primary endpoint outside of the U.S. iii. 48% achieved clinically meaningful reduction in itch compared to 9% with placebo.
The safety profile of Dupixent observed through 16 weeks in children aged 6 months to 5 years was similar to the safety profile in patients 6 years and older with atopic dermatitis. The long-term safety profile of Dupixent in children aged 6 months to 5 years through 52 weeks was also similar to the safety profile observed in the pivotal trial and consistent with what was observed in older patients with atopic dermatitis.
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