Dupixent Has Company. The FDA Has Approved Another Biologic for the Treatment of Atopic Dermatitis.

The FDA has approved Adbry (tralokinumab-ldrm) injection for the treatment of moderate-to-severe atopic dermatitis in adults whose condition is not controlled with prescription topical agents or when topical therapies are not advisable.

Adbry joins IL-4 receptor antagonist Dupixent (dupilumab) as the second biologic FDA-approved to treat atopic dermatitis. The FDA approved Dupixent in 2017. The approval of Adbry was announced on Dec. 28, 2021. The new treatment is expected to be available in pharmacies next month.

Atopic dermatitis, also called eczema, is a chronic inflammatory skin condition typically characterized by patches of red, dry, itchy, and scaly skin. Excessive scratching of lesions can cause the skin to break, which can lead to skin infections and other complications. Symptoms can significantly affect quality of life, causing sleep disruptions, anxiety, and depression in some cases. Interleukin (IL)-13 was recently identified as a culprit cytokine in inflammation, skin infection, and other symptoms associated with atopic dermatitis.

Adbry, which was developed by Leo Pharma, is a fully human monoclonal antibody that specifically binds to IL-13 and blocks its inflammatory effects. It is the first FDA-approved biologic that binds to and inhibits IL-13. Adbry is administered by subcutaneous injection and can be used with or without topical corticosteroids.

Adbry’s FDA approval was based on the results from three randomized, double-blind, phase III clinical trials. The ECZTRA 1 and ECZTRA 2 trials evaluated the safety and efficacy of Adbry in adults with moderate-to-severe atopic dermatitis. The ECZRA 3 trial assessed the safety and efficacy of Adbry in combination with topical corticosteroids in adults with moderate-to-severe atopic dermatitis. Primary endpoints for all trials included clear or almost clear skin at week 16 based on Investigator’s Global Assessment (IGA) scores and at least 75% improvement in Eczema Area and Severity Index (EASI) at week 16. A higher percentage of patients taking Adbry alone or with topical corticosteroids met all endpoints at week 16 than those in the placebo groups, and the frequency of adverse effects was comparable to that of placebo in all trials.