The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for dupilumab as an add-on maintenance treatment for moderate to severe atopic dermatitis in pediatric patients aged 6 months to 5 years whose disease is not adequately controlled with topical therapies or when those therapies are not advisable.
The sBLA is supported by data from the phase 3 LIBERTY AD PRESCHOOL study (ClinicalTrials.gov Identifier: NCT03346434), which evaluated the safety and efficacy of dupilumab added to low potency topical corticosteroids (TCS) vs low potency TCS alone in 162 children aged 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis. In the study, patients received dupilumab 200mg (weight ≥5 to <15kg) or 300mg (weight ≥15 to <30kg) subcutaneously every 4 weeks.
The primary endpoint was the proportion of patients achieving an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at week 16. Itch was also assessed using a caregiver-reported Numerical Rating Scale (0 to 10).
At week 16, results showed that 28% of patients treated with dupilumab achieved an IGA score of 0 or 1 vs 4% of the placebo group (P <.0001). Dupilumab-treated patients also experienced a 70% average improvement from baseline in disease severity compared with a 20% improvement with placebo (P <.0001). Moreover, dupilumab was associated with a 49% average improvement from baseline in itch vs 2% improvement for placebo (P <.0001).
As for safety, the most common adverse events reported were conjunctivitis and herpes viral infections. Safety results were found to be generally consistent with those observed in atopic dermatitis trials involving patients 6 years of age and older.
The FDA has set a Prescription Drug User Fee Act target date of June 9, 2022 for its decision on the application. If approved, dupilumab would be the first biologic in the US to treat uncontrolled moderate to severe atopic dermatitis in this age group.
Dupilumab is currently marketed under the brand Dupixent for the treatment of moderate to severe atopic dermatitis in patients 6 years of age and older; for maintenance treatment of severe asthma in patients 12 years of age and older; and for chronic rhinosinusitis with nasal polyps in patients 18 years of age and older.
- FDA accepts Dupixent® (dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. News release. Accessed February 10, 2022. https://www.prnewswire.com/news-releases/fda-accepts-dupixent-dupilumab-for-priority-review-in-children-aged-6-months-to-5-years-with-moderate-to-severe-atopic-dermatitis-301479373.html
- Positive phase 3 Dupixent® (dupilumab) data in children 6 months to 5 years with moderate to severe atopic dermatitis featured in RAD 2021 late-breaking session. News release. December 13, 2021. Accessed February 10, 2022. https://investor.regeneron.com/news-releases/news-release-details/positive-phase-3-dupixentr-dupilumab-data-children-6-months-5