The FDA expanded the approval of dupilumab (Dupixent) on Monday to include treatment of moderate-to-severe atopic dermatitis in patients ages 12 to 17, manufacturers Regeneron and Sanofi announced.
Dupilumab, which was already approved for atopic dermatitis in adults, can be used with or without topical corticosteroids. The drug addresses the inflammation underlying atopic dermatitis by targeting the IL-4/IL-13 pathway.
"For the first time, adolescents with uncontrolled moderate-to-severe atopic dermatitis have an approved biologic treatment option to help control persistent, often debilitating symptoms such as chronic itch and widespread rash," said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, in a statement. "Given that Dupixent targets a key pathway in type 2 inflammation, we are also investigating it in a broad development program in patients with other type 2 inflammatory diseases."
The agent is also approved for moderate-to-severe asthma in adolescents and adults.
The expanded approval in atopic dermatitis was based on a phase III trial assessing dupilumab monotherapy in patients ages 12 to 17 with uncontrolled moderate-to-severe disease.
From baseline, the average improvement in Eczema Area and Severity Index (EASI) for dupilumab-treated patients was about 66% at week 16 compared with 24% for placebo. Other endpoints also favored dupilumab over placebo -- reductions in itching (37% vs 5%, respectively) and completely clear or nearly clear skin (24% vs 2%).
Over five times as many participants on dupilumab had disease improvement of 75% or more (EASI-75) compared with those on placebo (42% vs 8%).
Common adverse events with dupilumab included throat pain, cold sores, red eyelid or eye inflammation, itching, swelling, and injection site reactions.
Atopic dermatitis, a type of eczema, is a chronic inflammatory condition with symptoms that often surface as a rash. In cases of moderate-to-severe disease, the rashes can cover a substantial portion of the body and can lead to skin dryness, redness, crusting, oozing, cracking, and persistent or intense itching.
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