Severe Atopic Dermatitis Treatment Approved for Children in Europe

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Commission (EC) had approved Dupixent® in the European Union to treat severe atopic dermatitis in children aged six months to 5 years old who are candidates for systemic therapy.

With this approval on March 21, 2023, Dupixent is the first and only targeted medicine indicated to treat these children in Europe and the U.S.

Dupixent is a fully human monoclonal antibody injection administered under the skin at different injection sites.

Atopic dermatitis is a chronic type 2 inflammatory skin disease. Between 85% and 90% of patients first develop symptoms before five years of age, which can often continue through adulthood.

“Watching an infant or young child grapple with the debilitating and wide-reaching impacts of severe atopic dermatitis is heartbreaking,” said Korey Capozza, MPH, Founder and Executive Director of Global Parents for Eczema Research, in a press release.

“I’ve personally witnessed how this chronic skin disease can disrupt the lives of entire families when left uncontrolled. However, intervening with effective treatments during infancy and early childhood can help manage the challenging impact this disease has on children and their families during such formative years.”

Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers. Treatment options in this age group are primarily topical corticosteroids, which can be associated with safety risks and may impair growth when used long-term.

The approval is based on data from a Phase 3 trial evaluating Dupixent every four weeks (200 mg or 300 mg based on body weight) plus low-potency primarily topical corticosteroids (TCS) or TCS alone (placebo) in 162 children aged six months to 5 years with moderate-to-severe atopic dermatitis.

At 16 weeks, Dupixent improved skin clearance and reduced overall disease severity and itch compared to placebo in the overall enrolled population. However, in a subset of those with severe atopic dermatitis, patients randomized to Dupixent (n=63) experienced the following compared to placebo (n=62) at 16 weeks:

• In addition, 46% of patients achieved 75% or greater improvement in overall disease severity compared to 7% treated with placebo, a co-primary endpoint.
• 14% of patients achieved clear or almost clear skin compared to 2% treated with placebo, a co-primary endpoint.
• 55% average reduction in overall disease severity from baseline compared to 10% with placebo.
• 42% average reduction in itch from baseline compared to a 1% increase with placebo.

Dupixent also improved sleep quality, skin pain, and health-related quality of life compared to placebo in both the overall and severe populations. In addition, long-term efficacy data showed the clinical benefit at 16 weeks was sustained through 52 weeks.

The most common side effects across indications include injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia. 

Dupixent is currently approved for one or more indications in more than 60 countries, including Europe, the U.S., and Japan. More than 600,000 patients are being treated with Dupixent globally.