FDA OKs Dupilumab For Adolescent AD

Officials with the US Food and Drug Administration (FDA) have approved dupilumab (Dupixent, Regeneron and Sanofi) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids, according to a statement from Regeneron about the approval.

Dupilumab is a biologic therapy that inhibits signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13). In the phase 3 trial evaluating Dupixent monotherapy in adolescent patients with uncontrolled moderate-to-severe atopic dermatitis, the safety and efficacy were generally consistent with that previously seen in adult studies. With this approval, dupilumab is now the first biologic therapy approved for the patient population.

At 16 weeks the average improvement in the eczema area and severity index from baseline was approximately 66% compared to 24% for placebo, and more than 10 times as many patients had clear or almost clear skin with Dupixent compared to placebo.

Dupixent has been studied in more than 7,000 patients 12 years and older in over 30 clinical trials. The safety profile of Dupixent in the adolescent trial was similar to the safety profile from trials in adults with atopic dermatitis, and consistent through 52 weeks. The most common adverse events were injection site reactions, eye and eyelid inflammation including redness, swelling and itching, pain in the throat (oropharyngeal pain) and cold sores in the mouth or on the lips.

Atopic dermatitis is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. Moderate-to-severe atopic dermatitis is characterized by rashes that can potentially cover much of the body and can include intense, persistent itching, skin lesions and skin dryness, cracking, redness, crusting and oozing. Itch is one of the most burdensome symptoms for patients and can be debilitating.