FDA Approves Dupilumab for Atopic Dermatitis in Children

Officials with the FDA today approved dupilumab (Dupixent, Sanofi and Regeneron) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis (AD) not well controlled with topical prescription medications, according to a press release.

With this approval, dupilumab is the only biologic medicine approved for this patient population, according to Sanofi.

Dupilumab, a fully-human monoclonal antibody, inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. The FDA’s approval for dupilumab’s use in this population is based on data from a phase 3 clinical study, which evaluated the efficacy and safety of dupilumab combined with topical corticosteroids (TCS) compared with TCS alone in children with severe AD.

The results of the study showed that children treated with dupilumab plus TCS experienced significant improvements in overall disease severity, skin clearance, and itch.

The results at 16 weeks showed:

• Eighty-four percent improvement in average Eczema Area and Severity Index (EASI) from baseline in patients who received dupilumab every 4 weeks and 80% in patients who received dupilumab every 2 weeks, compared with 49% and 48% for TCS alone, respectively.

• Seventy-five percent of patients who received dupilumab every 4 weeks and 75% of patients who received dupilumab every 2 weeks achieved EASI-75 compared with 28% and 26% for TCS alone, respectively.

• Fifty-four percent of patients who received dupilumab every 4 weeks and 61% of patients who received dupilumab every 2 weeks experienced at least a 4-point reduction in itch intensity on a 0 to 10-point scale (weekly average of daily Peak Pruritus Numerical Rating Scale), compared with 12% and 13% for TCS alone, respectively.

• Thirty percent of patients who received dupilumab every 4 weeks and 39% of patients who received dupilumab every 2 weeks achieved clear or almost clear skin, compared with 13% and 10% for TCS alone, respectively.

Additionally, the safety profile of dupilumab with TCS was consistent with what was observed in adults and adolescent populations with AD. Overall rates of adverse events were 65% for dupilumab every 4 weeks, 61% for dupilumab every 2 weeks, and 72% and 75% for TCS alone, respectively.

Dupilumab comes in 2 doses, prescribed based on weight (300 mg every 4 weeks for children ≥15 to <30 kg and 200 mg every 2 weeks for children ≥30 to <60 kg, following an initial loading dose), as a pre-filled syringe for pediatric patients aged 6 to 11 years, according to Sanofi.

“This approval brings the paradigm-changing efficacy and established safety profile of Dupixent to children with moderate-to-severe atopic dermatitis,” George D. Yancopoulos, MD, PhD, cofounder, president, and chief scientific officer at Regeneron, said in a statement. “We continue to study Dupixent in even younger children with uncontrolled moderate-to-severe atopic dermatitis from 6 months to 5 years old, as well as in children with uncontrolled, persistent asthma. Additionally, we are investigating Dupixent in other diseases driven by type 2 inflammation including eosinophilic esophagitis, food and environmental allergies, chronic obstructive pulmonary disease, and other dermatologic diseases.”