The US Food and Drug Administration (FDA) gave its nod to Dupixent (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis (AD).

Dupixent comes in two doses, prescribed based on weight (300 mg every four weeks for children ≥15 to <30 kg and 200 mg every two 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. 

The approval is based on data from a pivotal Phase 3 trial which found that more than twice as many children achieved clear or almost clear skin and more than four times achieved itch reduction with Dupixent plus topical corticosteroids (TCS) compared to TCS alone. Children treated with Dupixent and topical corticosteroids (TCS) experienced approximately 80 percent average overall disease improvement.

Results at 16 weeks showed:

  • 84 percent improvement in average EASI (Eczema Area and Severity Index) score from baseline in patients who received Dupixent every four weeks and 80 percent in patients who received Dupixent every two weeks, compared to 49 percent and 48 percent for TCS alone, respectively.
  • 75 percent of patients who received Dupixent every four weeks and 75 percent of patients who received Dupixent every two weeks achieved EASI-75 (Eczema Area and Severity Index-75), compared to 28 percent and 26 percent for TCS alone, respectively.
  • 54 percent of patients who received Dupixent every four weeks and 61 percent of patients who received Dupixent every two 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 to 12 percent and 13 percent for TCS alone, respectively.
  • 30 percent of patients who received Dupixent every four weeks and 39 percent of patients who received Dupixent every two weeks achieved clear or almost clear skin (Investigator's Global Assessment or IGA), compared to 13 percent and 10 percent for TCS alone, respectively.

The safety profile of Dupixent with TCS was similar to what was observed in adults and adolescents with atopic dermatitis, and consistent through 52 weeks. Safety data over the 16-week treatment period showed:

  • Overall rates of adverse events (AEs) were 65 percent for Dupixent every four weeks, 61 percent for Dupixent every two weeks, and 72 percent and 75 percent for TCS alone, respectively.
  • AEs that were more commonly observed with Dupixent included upper respiratory tract infections (15 percent for Dupixent every four weeks, 9 percent for Dupixent every two weeks, and 8 percent and 12 percent for TCS alone, respectively), injection site reactions (10 percent for Dupixent every four weeks, 14 percent for Dupixent every two weeks, and 7 percent and 5 percent for TCS alone, respectively), nasopharyngitis (10 percent for Dupixent every four weeks, 3 percent for Dupixent every two weeks, and 3 percent and 10 percent for TCS alone, respectively), conjunctivitis (7 percent for Dupixent every four weeks, 9 percent for Dupixent every two weeks, and 3 percent and 5 percent for TCS alone, respectively), vomiting (5 percent for Dupixent every four weeks, 7 percent for Dupixent every two weeks, and 7 percent and 7 percent for TCS alone, respectively) and fever (5 percent for Dupixent every four weeks, 2 percent for Dupixent every two weeks, and 7 percent and 0 percent for TCS alone, respectively).

Additional prespecified AEs across all weight groups and doses included skin infections (6 percent for Dupixent every four weeks, 8 percent for Dupixent every two weeks, and 13 percent for TCS alone), which is noteworthy because patients with atopic dermatitis have an increased risk of skin infections. In adult atopic dermatitis trials, the incidence of serious skin infections was 57 percent less with Dupixent compared to the control groups. In addition, in the pediatric trial (6-11 years of age), herpes viral infections occurred in 0 percent of Dupixent patients every four weeks, 2 percent of Dupixent patients every two weeks, and 5 percent for patients on TCS alone.

"This approval brings the paradigm-changing efficacy and established safety profile of Dupixent to children with moderate-to-severe atopic dermatitis. This young, vulnerable population struggles with debilitating symptoms and disease covering over half of their body, impacting them and their families who spend countless hours helping them manage their disease," says George D. Yancopoulos, M.D., Ph.D., Co-founder, President and Chief Scientific Officer at Regeneron, in a news release. "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."

"This FDA approval is another milestone in the journey for Dupixent as an innovative biologic treatment for atopic dermatitis and other conditions driven in part by type 2 inflammation," adds John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "Caregivers of children with moderate-to-severe atopic dermatitis and their physicians now have access to a first-in-class biologic with a proven safety profile, a factor that often plays a critical role in treatment decisions for younger patients. Additionally, improvements in itch and disease severity were observed as early as two weeks after the first dose and continued throughout active treatment, which is important for these children and their families."

The FDA evaluated the Dupixent application under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. The FDA previously granted Breakthrough Therapy designation to Dupixent for the treatment of severe atopic dermatitis in children 6 months to 11 years of age not well controlled on topical prescription medications. The Breakthrough Therapy designation was created to expedite the development and review of drugs developed for serious or life-threatening conditions.