BRIEF—Lilly submits BLA to FDA for atopic dermatitis med

US pharma major Eli Lilly has submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for lebrikizumab, an investigational interleukin (IL)-13 inhibitor for the treatment of moderate-to-severe atopic dermatitis (AD).

AD is an IL-13 dominant disease in which IL-13 drives skin barrier dysfunction, itch, skin thickening and susceptibility to infection. Lebrikizumab is designed to bind IL-13 with high affinity, slow disassociation rate and high potency to inhibit the biological effects of IL-13.

The submission is supported by the  ADvocate 1 and ADvocate 2 16-week and 52-week results, as well as the  ADhere 16-week results, which are randomized, double-blind, placebo-controlled, parallel-group, global, Phase III studies that evaluated the efficacy and safety of lebrikizumab as a monotherapy and in combination with standard-of-care topical corticosteroids in adolescents and adults (12 years of age or older).

The atopic dermatitis (AD) market is expected to grow from a value of $6.4 billion in 2020 to $16.8 billion in 2030 in the seven major markets at a compound annual growth rate (CAGR) of 10.1%, according to GlobalData.