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Dupilumab Receives FDA Priority Review and Accepts sBLA for Children 6 Months to 5 Years


If approved, dupilumab will be the first biologic medicine available in the US to treat uncontrolled moderate to severe atopic dermatitis for young children 6 months to 5 years old.

Regeneron Pharmaceuticals, Inc. and Sanofi S.A. announced the FDA has accepted for priority review the supplemental biologics license application (sBLA) for dupilumab (Dupixent; Regeneron and Sanofi) as an add-on maintenance treatment for children aged 6 months to 5 years with moderatetosevere atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.1 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 target action date for the FDA decision on this investigational use is June 9, 2022. Dupilumab remains the only biologic medicine approved for patients 6 years of age and older in this indication, the press release explained.

The sBLA is supported by data from the LIBERTY AD trial (NCT03346434), a phase 3 trial evaluating the efficacy and safety of dupilumab added to standard-of-care topical corticosteroids (TCS) in children aged 6 months to 5 years with uncontrolled moderatetosevere AD. The trial met all primary and secondary endpoints.1 

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.

Safety results were generally consistent with the safety profile of dupilumab in AD for patients aged 6 years and older. The most common adverse events (AEs) that were more commonly observed with dupilumab included conjunctivitis and herpes viral infections.

If approved, dupilumab will be the first biologic medicine available in the United States to treat uncontrolled moderatetosevere AD for these young children


1. FDA accepts dupixent (dupilumab) for priority review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis.Regeneron Pharmaceuticals Inc. Press release. Published February 10, 2022. Accessed February 10, 2022. https://investor.regeneron.com/news-releases/news-release-details/fda-accepts-dupixentr-dupilumab-priority-review-children-aged-6/

2. Dupilumab demonstrates safety, efficacy in pediatric ad patients ages 6 months to 5 years. Dermatology Times. Published August 31, 2021. Accessed February 10, 2022. https://www.dermatologytimes.com/view/dupilumab-demonstrates-safety-efficacy-in-pediatric-patients-ages-6-months-to-5-years 

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