FDA approves Adbry for atopic dermatitis.
Adbry can be used with or without topical corticosteroids.
The approval of Adbry is based on safety and efficacy results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase III trials, which included nearly 2,000 adult patients with moderate-to-severe atopic dermatitis. Safety data was evaluated from a pool of five randomized, double-blind, placebo-controlled trials, including ECZTRA and ECZTRA 3, a dose-finding trial, and a vaccine response trial. Adbry will be available in a 150 mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week.
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