FDA OKs First Biologic for Children Under 5 With Moderate-to-Severe Atopic Dermatitis

Sanofi has announced the US FDA approval of Dupixent (dupilumab) as the first biologic medicine to treat children aged 6 months to 5 years with moderate-to-severe atopic dermatitis (eczema). The drug was previously FDA approved for children aged 6 to 11 years with the disease in 2020. 

A regulatory filing for the same age group is under review by the European Medicines Agency and submissions to regulatory authorities in other countries are underway. 

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Clearer Skin and Reduced Itch 

“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 Black, President and CEO of the National Eczema Association. 

For many children, topical treatments do not adequately control the disease. In the US alone, more than 75,000 children under the age of 5 have uncontrolled moderate-to-severe disease, with most needing new treatment options. 

Dupixent is a fully-human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, which are thought to drive type 2 inflammation in atopic dermatitis. 

The latest FDA approval for the drug is based on results from a Phase 3 trial assessing Dupixent plus low-potency topical corticosteroids (TCS) or placebo (TCS alone). 

During the trial, Dupixent was administered every 4 weeks based on weight (200 mg for children ≥5 to <15 kg and 300 mg for children ≥15 to <30 kg). The trial met its primary endpoint, achieving an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area and Severity Index at week 16. 

All secondary endpoints were also met, which included clinically meaningful itch reduction at week 16. 

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. 

Side effects include hand-foot-and-mouth disease and skin papilloma, reported in 5% and 2% of Dupixent patients aged 6 months to 5 years respectively. None of these cases led to treatment discontinuation.

Children who completed the trials were eligible to enroll in an open-label extension trial to assess the safety and efficacy of long-term treatment with Dupixent in this age group.

Blockbuster Drug in the Making

Dupixent is the result of a 15-year long collaboration between Sanofi and Regeneron. The drug began turning a profit for the drugmakers in 2019, fuelled by a clutch of approvals in prevalent diseases such as eczema, asthma and nasal polyps. 

In 2021, worldwide sales of Dupixent surpassed $5.6 billion (up 52.7% from the previous year), of which over $4.2 billion were generated in the US.

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Joy Lin

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