The regulatory approval has been granted for the therapy to treat moderate-to-severe atopic dermatitis in children whose disease is not controlled with topical prescription therapies or when they are not advisable.
This makes Dupixent the first and only biologic medicine available in the US to treat uncontrolled moderate-to-severe atopic dermatitis in this age group.
A fully human monoclonal antibody, Dupixent has been designed to block the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways signalling.
Sanofi Immunology and Inflammation Global Development head, senior vice-president Naimish Patel said: “Until today, treatment options in the US for infants and children under the age of six suffering from moderate-to-severe atopic dermatitis have been limited to topical steroids – which may be associated with significant safety risks when used long-term.
“This has left patients and their caregivers in desperate need of medicines that can better address the chronic, long-term nature of the disease.
“These young people, and their families, often struggle to cope with the significant impact itch can have on them.”
The FDA approval was based on data obtained from a double-blind, placebo-controlled, randomised Phase III trial.
The trial assessed the safety and efficacy of the antibody added to low-potency topical corticosteroids (TCS) compared to TCS alone (placebo).
It involved 162 children aged six months to five years, who were given 200mg or 300mg dupilumab dose depending on their body weight, along with low-potency TCS.
The findings showed that 28% of the children treated with dupilumab had achieved clear or almost clear skin compared to 4% who were given placebo.
Furthermore, 53% of dupilumab-treated group achieved 75% or greater improvement in overall disease severity from baseline compared to 11% who were treated with placebo, and 48% of children treated with dupilumab achieved clinically meaningful itch reduction.