The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Priority Review for the use of Dupixent (dupilumab) in children aged six months to five years with moderate-to-severe atopic dermatitis. The FDA’s decision on the investigational use of Dupixent is expected on 9 June 2022.
If approved, Dupixent – developed by Regeneron Pharmaceuticals and Sanofi Genzyme – would be used as a supplementary treatment for managing moderate-to-severe atopic dermatitis and is aimed at children whose condition is not adequately treated with topical prescriptions, or for those who are advised against used topical treatments.
Dupixent is currently the only biologic treatment approved for patients aged six years and older with the condition who meet the guidelines for use. The drug can be used either with or without topical corticosteroids. For children in these particular age groups, the only current treatment options available are topical steroids, which carry safety risks and may impair the child’s growth if used as a long-term measure.
As a chronic, type 2 inflammatory skin disease, it has been recorded that 85-95% of atopic dermatitis patients experience symptoms before the age of five, with symptoms often continuing into adulthood. Symptoms can include persistent itching and skin lesions covering the body, and the chance of skin infections is also a concern for patients.
For children suffering with the condition, their quality of life can be significantly impacted, which can have a knock-on effect for the parents and caregivers supporting them.
The sBLA is supported by evidence from the phase 3 trial which evaluated the effectiveness and safety profile of Dupixent when used to supplement topical corticosteroids. The trial showed that Dupixent and topical corticosteroids helped to significantly improve skin condition and reduced overall disease severity and itching at 16 weeks, when compared to using topical corticosteroids alone.