Dupilumab FDA approved for AD patients 6 months to 5 years


Sanofi and Regeneron Pharmaceuticals, Inc announced the FDA approval of dupilumab. It is now the first biologic medicine for children from 6 months to 5 years old with moderate to severe atopic dermatitis.

The FDA has approved dupilumab (Dupixent; Sanofi and Regeneron Pharmaceuticals, Inc) 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, according to a press release. This filing is also under review by the European Medicines Agency (EMA) for this age group along with and submissions to regulatory authorities in other countries worldwide. Dupilumab is a fully human monoclonal antibody that inhibits the signaling of the interleukin (IL)-4 and IL-13 pathways and is not an immunosuppressant.

The president and CRO of the National Eczema Association, Julie Block, commented on the approval and said, “moderate-to-severe atopic dermatitis in babies and young children is more than just a rash – the intense itch can make them scratch uncontrollably throughout the day and night and cause their skin to crack and bleed.” She continued, “caregivers do their best to manage skincare routines multiple times a day, but for many, topical treatments are not enough. We’re pleased to see how scientific innovation and research continues to address unmet needs for the atopic dermatitis community, and we’re hopeful for the positive impact Dupixent can have for these children and their families."

Most patients, 85%-90%, first have AD symptoms before the age of 5 years, which often affect them into the later years of their lives.

Dupilumab submitted for priority review from the FDA, which was accepted in February 2022, and had an original target action date of June 9, 2022.

The approval was supported by data from the LIBERTY AD trial (NCT03346434), a phase 3 trial evaluating dupilumab every 4 weeks (200 mg or 300 mg, based on body weight) plus low-potency topical corticosteroids (TCS) or TCS alone (placebo) in pediatric patients aged 6 months to 5 years with uncontrolled moderate to severe AD. The trial met all primary and secondary endpoints.

The analysis found that at 16 weeks patients treated with dupilumab:2

  • Twenty eight percent achieved clear or almost-clear skin compared to 4% with placebo;
  • fifty three percent achieved 75% or greater overall disease improvement from baseline compared to 11% with placebo;
  • seventy percent average improvement from baseline in EASI 75 compared to 20% improvement with placebo;
  • forty nine percent average improvement from baseline in itch compared to 2% improvement with placebo; and
  • significantly improved measures of observed patient outcomes (including sleep, skin pain and health-related quality of life), as well as caregiver-reported health-related quality of life.

The data found that the safety profile in this trial was like the safety profile in patients 6 years and older with AD. The long-term (52 weeks) safety profile of patients receiving active treatment found it was also consistent. The most common adverse event was hand-foot-and-mouth disease and skin papilloma reported in 5% and 2% of patients treated with dupilumab aged 6 months to 5 years, respectively, and none of these cases led to treatment discontinuation.

“This approval is a tremendous advancement for children as young as six months old with moderate-to-severe atopic dermatitis, as there is a large unmet need in this population and we’ve seen what Dupixent can do for older children and adults with this disease,” said Mercedes E. Gonzalez, MD, FAAD, pediatric dermatologist at Pediatric Dermatology of Miami. “Dupixent is a very welcome addition to our treatment options, which up until recently, primarily included potent topical steroids. Now we have something that targets an underlying cause of the disease, and may change the trajectory of their childhood by removing the burden of moderate to severe eczema from their lives, hopefully making the future brighter for these children.”


Press Release: FDA approves Dupixent® (Dupilumab) as first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. GlobeNewswire News Room. Published July 6, 2022. Accessed June 8, 2022. https://www.globenewswire.com/news-release/2022/06/07/2458243/0/en/Press-Release-FDA-approves-Dupixent-dupilumab-as-first-biologic-medicine-for-children-aged-6-months-to-5-years-with-moderate-to-severe-atopic-dermatitis.html

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