LEO Pharma announced today that it received FDA approval for its Adbry injection treatment for moderate-to-severe atopic dermatitis.

Ballerup, Denmark-based LEO Pharma designed its Adbry injection for treating atopic dermatitis in adults aged 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

According to a news release, Adbry can be used with or without topical corticosteroids and is the first and only FDA-approved biologic that specifically binds to and inhibits the IL-13 cytokine.

LEO Pharma received approval based on safety and efficacy results from the Eczstra 1, 2 and 3 pivotal Phase 3 trials, which observed nearly 2,000 adult patients.

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 week. LEO Pharma will introduce the Adbry Advocate program to support U.S. patients at diagnosis and through treatment with the injection.

“Today’s FDA approval of Adbry is a major milestone for LEO Pharma and for the millions of people living with moderate-to-severe atopic dermatitis who struggle to find a suitable treatment option for this chronic and debilitating disease,” LEO Pharma CFO & Acting CEO Anders Kronborg said in the release. “As our first biologic in the U.S., Adbry signifies important progress in our mission of advancing the standard of care in medical dermatology.”