FDA OKs Dupilumab for Moderate-to-Severe Eczema in Teens

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The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent, Sanofi/Regeneron) for adolescents aged 12 to 17 years with moderate-to-severe atopic dermatitis poorly controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.

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Dupilumab is a targeted biologic therapy that inhibits interleukin-4 and interleukin-13, which may play a central role in type 2 inflammation involved in atopic dermatitis and other allergic diseases.

The FDA approved dupilumab for adults with moderate-to-severe atopic dermatitis in 2017.

In a phase 3 trial evaluating dupilumab monotherapy in adolescents with uncontrolled moderate-to-severe atopic dermatitis, the safety and efficacy were generally consistent with those previously seen in studies involving adults, the company said in a news release.

Among the key findings in the adolescent trial at 16 weeks:

• Average improvement from baseline in the Eczema Area and Severity Index (EASI) score was roughly 66% compared with 24% with placebo

• 24% of patients treated with dupilumab achieved clear or almost clear skin compared with just 2% of patients treated with placebo, as measured by an Investigator Global Assessment score of 0 or 1 (the primary endpoint)

• 42% of patients achieved 75% (EASI-75) or greater skin improvement with dupilumab versus 8% with placebo, as measured by EASI

• 37% of patients treated with dupilumab achieved a clinically meaningful improvement in itch of at least four points on the Peak Pruritus Numerical Rating Scale compared with 5% with placebo

Dupilumab has been studied in more than 7000 patients aged 12 years or older in over 30 clinical trials, the company said. The safety profile in adolescents is similar to that in adults. The most common adverse events were injection-site reactions, eye and eyelid inflammation including redness, swelling and itching, oropharyngeal pain, and cold sores in the mouth or on the lips.

Dupilumab for subcutaneous injection comes in two doses (200 mg and 300 mg), each as a prefilled syringe. It is given every other week following an initial loading dose. It can be given in a clinic or self-administered at home after training by a healthcare professional.

In a statement, Emma Guttman-Yassky, MD, PhD, professor of dermatology, Icahn School of Medicine at Mount Sinai in New York City, one of the primary investigators in the phase 3 dupilumab studies in children, said, "This drug is revolutionizing the way we can treat atopic dermatitis, a very prevalent and debilitating disease and is creating a new treatment paradigm of safer drugs for long-term disease control. It is truly a game changer for those suffering with this disease and is also opening the door to rapid therapeutic development in AD [atopic dermatitis] drugs."

"Up to now treatments for adolescent patients with moderate to severe AD or eczema used immune suppressants that harbor many side effects and are not suitable for long term use, leading to a huge unmet need for safer and more effective treatments," Guttman-Yassky said.

Dupilumab is a biologic antibody targeted against specific lymphocytes that are upregulated in eczema. "It is more of an 'immune correcting' rather than immune suppressing drug," she added.

Dupilumab had breakthrough therapy designation and received priority review, a regulatory process reserved for medicines that represent potentially significant improvements in safety or efficacy in treating serious conditions.

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