FDA Accepts Dupixent for Priority Review in Young Children With Atopic Dermatitis


If approved, Dipilumab will be the first biologic medicine available in the United States to treat uncontrolled moderate-to-severe AD for patients aged 6 months to 5 years.

The FDA has accepted for priority review the supplemental biologics license application (sBLA) for dupilumab (Dupixent, Regeneron Pharmaceuticals, Sanofi) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable, the pharmaceutical companies said in a statement.1The target action date for the FDA decision on this investigational use is June 9, 2022.1

Dupixent is the only biologic medicine approved for patients aged 6 years or older for this indication.1

The sBLA is supported by data from the pivotal phase 3 trial evaluating the efficacy and safety of the drug when added to standard-of-care topical corticosteroids (TCS) in children who were aged 6 months to 5 years with uncontrolled moderate-to-severe AD.1

The trial met all primary and secondary endpoints, showing that Dupixent and TCS significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared with TCS alone.1

The safety results were generally consistent to the safety profile of Dupixent in AD for individuals aged 6 years and older.1

The most common adverse events observed included conjunctivitis and herpes viral infections.1

In 2016, the FDA granted breakthrough therapy designation for Dupixent for the treatment of severe AD in children aged 6 months to 11 years.1

AD is a chronic type 2 inflammatory skin disease where 85% to 90% of individuals develop symptoms before aged 5 years old, and it can continue through adulthood, investigators said.1

Moderate-to-severe AD may also significantly affect the quality of life of children, their parents, and caregivers.1

Symptoms of AD can include cracking; crusting and oozing; increased risk of skin infections, intense, persistent itch and skin lesions resulting in skin dryness; pain, and redness.1

Treatment options in this age group are primarily topical steroids, which can be associated with safety risks and may impair growth if used long term.1

Dupixent is also indicated for use with other asthma medications for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid-dependent asthma in individuals aged 6 years and older whose asthma is not controlled with their current medications.1

Additionally, it is indicated for use with other medications for the maintenance treatment of chronic rhinosinusitis with nasal polyposis in adults whose disease is not controlled.1

Approximately 9.6 million individuals in the United States under aged 18 years have, AD, with nearly one-third having moderate-to-severe AD, according to the National Eczema Association.2

For adults in the United States, an estimated 16.5 million had AD that initially began after aged 2 years, with nearly 40% of them having moderate-to-severe AD.2


1. FDA accepts Dupixent (dupilumab) for priority review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. Regeneron. News release. February 10, 2022. Accessed February 14, 2022. https://investor.regeneron.com/news-releases/news-release-details/fda-accepts-dupixentr-dupilumab-priority-review-children-aged-6

2. Eczema stats. National Eczema Association. Accessed February 14, 2022. https://nationaleczema.org/research/eczema-facts/#:~:text=Prevalence%20of%20Childhood%20%26%20Adult%20Atopic%20Dermatitis%20(AD)&text=An%20estimated%2016.5%20million%20U.S.,by%20moderate%20or%20severe%20disease.&text=Atopic%20dermatitis%20is%20not%20solely,adult%2Donset%20of%20initial%20symptoms

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