FDA accepts Dupixent (dupilumab) for children with moderate-to-severe atopic dermatitis

pharmafile | February 10, 2022 | News story | Business Services  

The FDA has accepted the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) for children aged six months to five years with moderate-to-severe atopic dermatitis. This add-on treatment is recommended for children whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Dupixent is the only biologic medicine approved for patients six years of age and older in this indication.

Atopic dermatitis is a chronic type 2 inflammatory skin disease, and 85 to 90% of patients develop symptoms (onset of disease), before five years of age, which can often continue through adulthood. Symptoms include intense, persistent itch, and skin lesions that cover most of the body, resulting in skin dryness, cracking, pain, redness or darkening. This disease will also significantly impact the quality of life of a young child, their parents, and caregivers.

Existing treatment options in this age group consist of topical steroids, which can have safety risks and are likely to impair growth when used long-term.

The sBLA is supported by data from the pivotal Phase III trial, evaluating the efficacy and safety of Dupixent, added to standard-of-care topical corticosteroids (TCS). The trial met all primary and secondary endpoints, demonstrating that Dupixent and TCS significantly improved skin clearance, and reduced overall disease severity and itch at 16 weeks compared to TCS alone.

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.

Lina Adams

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