Lilly Korea’s new atopic dermatitis drug ‘Ebglyss' receives approval

Elli Lilly Korea said its new atopic dermatitis drug Ebglyss (ingredient: lebrikizumab), an Interleukin (IL)-13 inhibitor, received approval from the Ministry of Food and Drug Safety (MFDS) on Monday.

The multifactorial pathogenesis of atopic dermatitis involves the interaction of impaired skin barrier function and genetic, immunological, and environmental factors. Type 2 helper T cells, which primarily produce cytokines such as IL-4, IL-13, and IL-31, play a significant role in the disease's development.

Elevated serum levels of IL-13 are particularly correlated with disease severity.

Ebglyss, a human monoclonal IgG4 antibody, binds with high affinity to IL-13, inhibiting the signaling pathways involved in atopic dermatitis by blocking the IL-4 receptor alpha (IL-4Rα) and IL-13 receptor alpha 1 (IL-13Rα1) heterodimer.

Ebglyss is approved for treating moderate to severe atopic dermatitis in adults and adolescents 12 and older weighing over 40 kg, who are inadequately controlled with topical prescription therapies or for whom those therapies are not advisable.

The initial treatment regimen for Ebglyss involves administering two 250 mg injections at weeks 0 and 2, followed by 250 mg subcutaneously every two weeks until week 16.

Patients who achieve clinical response at 16 weeks can continue with a maintenance dose of 250 mg every four weeks. Some patients showing partial response at the initial stage may continue the bi-weekly regimen for up to 24 weeks for additional improvement.

The domestic approval of Ebglyss was based on three randomized, double-blind, placebo-controlled, and therapeutic confirmatory phase 3 clinical trials -- ADvocate-1, ADvocate-2, and Adhere -- in 1,062 adults and adolescents with moderate to severe atopic dermatitis.

"We are delighted to introduce Ebglyss as a new biologic treatment for Korean people with moderate to severe atopic dermatitis, addressing the high unmet medical need,” Elli Lilly Korea Immunology Business Unit Director Kim Tae-hyun said. “Following the approvals of IL-17A inhibitor Talz, JAK inhibitor Olumiant, and IL-23 inhibitor Omvoh, the addition of IL-13 inhibitor Ebglyss strengthens our robust immunology portfolio.”