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FDA approves Adbry for atopic dermatitis.

Read time: 1 mins
Published:31st Dec 2021
LEO Pharma announced that the FDA has approved Adbry (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

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.

Condition: Atopic Dermatitis (Eczema)
Type: drug

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