The indication, designated for pediatric patients whose disease is not adequately or appropriately managed by topical prescription therapy, is the first granted to a biologic for this patient population.
The supplemental approval for the interleukin 4 and 13 (IL-4; IL-13) pathway-targeting monoclonal antibody from Sanofi and Regeneron Pharmaceuticals was based on findings from a phase 3 trial comparing dupilumab plus topical corticosteroids (TCS) versus lone TCS, at either 2 or 4 weeks dosing, in children with severe atopic dermatitis.
At 16 weeks, patients treated with add-on dupilumab every 4 weeks reported an 84% improvement in mean Eczema Area and Severity Index (EASI) score from baseline; patients receiving the biologic every 2 weeks reported 80% improvement; patients on lone TCS every 2 and 4 weeks reported improvements of just 48% and 49%, respectively.
EASI-75 was achieved in three-fourths of all dupilumab-treated patients, versus just over one-fourth (26%; 28%) of lone TCS-treated patients.
Investigators also observed significant improvements to patient Peak Pruritus Numerical Rating Scale itch intensity with the biologic plus TCS. Clear or almost clear skin, as per Investigators Global Assessment (IGA) scores of 0 or 1, were achieved in 39% and 30% of dupilumab-treated patients, versus just 10% and 13% of lone TCS patients, respectively.
Dupilumab plus TCS reported a safety profile consistent with that observed in adult and adolescent patients with atopic dermatitis through 52 weeks.
The biologic has been previously approved by the FDA for the treatment of moderate to severe atopic dermatitis and asthma in patients aged 12 years and older, as well as severe chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults.
Its specific pathway-targeting and inhibition mechanism has led investigators to assess its capability in a bevy of type 2 inflammatory conditions, including eosinophilic esophagitis, food and environmental allergies, and chronic obstructive pulmonary disease (COPD).
Phase 3 LIBERTY AD PEDS principal investigator Amy S. Paller, MD, Walter J. Hamlin Professor and Chair of Dermatology and Professor of Pediatrics at Northwestern University Feinberg School of Medicine, told HCPLive® last month dupilumab showed absolutely “no red flags” at 16 weeks in pediatric atopic dermatitis patients, while displaying unprecedented benefit for the young patient population.
She anticipated the FDA’s approval for this indication weeks in advance of the PDUFA date.
“This is a patient group that needs it so much, that I’m sure our FDA will help these families out,” she explained.
In a statement accompanying the decision, John Reed, MD, PhD, Global Head of Research and Development at Sanofi, called the newest approval “another milestone” in the campaign of dupilumab as an innovative biologic therapy across type 2 diseases.
“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,” Reed said. “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.”