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December 30, 2021December 28, 2022 – Leo Pharma's AdbryTM (tralokinumab-ldrm) has received FDA approval to treat moderate to severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or for whom such therapies are not advisable.
- Adbry is the first FDA-approved biologic that specifically targets IL-13 cytokines, a driver of the signs and symptoms of atopic dermatitis.
- Recommended initial dosing is 600mg (four 150mg subcutaneous injections), followed by a recommended maintenance dose of 300mg (two 150mg injections) once every other week. Patients below 100kg (220 pounds) who achieve clear or almost clear skin after 16 weeks of treatment may be able to switch to a maintenance dose of 300mg once every four weeks. Adbry can be self-administered or administered by a caregiver.
- Leo Pharma has launched the product at a wholesale acquisition cost (WAC) of $3,348.80 per one- month supply at a dosing schedule of 300mg every other week.