With this decision, dupilumab is now the only biologic medicine approved from infancy through adulthood for people with AD.
Today, the US Food and Drug Administration (FDA) approved dupilumab (Dupixent) for children 6 months to 5 years with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies.
This decision has made dupilumab the only biologic medicine approved from infancy through adulthood for people with AD.
The approval was supported by a phase 3 trial that evaluated the biologic every 4 weeks plus low-potency topical corticosteroids (TCS) compared to TCS alone.
The trial involved 162 children aged 6 months to 5 years who were issued either a 200 mg or 300 mg dupilumab dose, depending on their body weight. The safety profile of the biologic was then monitored continuously for 16 weeks.
The trial achieved its primary endpoint, as 28% of the children treated with dupilumab had achieved clear or almost clear skin compared to 4% who were treated with placebo.
Additionally, 53% of dupilumab-treated participants achieved 75% or greater improvement in overall disease severity from baseline compared to 11% with placebo, and nearly half (48%) of all children treated with the biologic achieved clinically meaningful itch reduction.
Notably, the safety profile from this trial was similar to that observed in adult patients with AD.
In a press release issued by Regeneron Pharmaceuticals, President and Chief Scientific Officer at Regeneron George D. Yancopoulos, MD, PhD, considered children with moderate to severe AD to be “a significantly underserved” patient population, and was confident that today’s approval would change the treatment paradigm for children affected by this disease. Dupixent is being developed by Regeneron and Sanofi.
“Today's approval brings the proven efficacy and, importantly, well-established safety profile of Dupixent to these young children, making it the first of its kind to be approved for any US patient aged 6 months or older living with this debilitating disease,” he said.