Eli Lilly launches atopic dermatitis drug Ebglyss in Korea

Eli Lilly Korea launched Ebglyss, a 250 mg pre-filled autoinjector containing lebrikizumab, for the treatment of moderate-to-severe atopic dermatitis, on Wednesday.

Ebglyss is a biologic therapy that targets interleukin-13 (IL-13), a cytokine associated with atopic dermatitis.

In August last year, it was approved by the Ministry of Food and Drug Safety for use in adults and adolescents aged 12 and older (weighing at least 40 kilograms) whose condition is not adequately controlled with topical therapies or for whom such treatments are not recommended.

Patients who respond to the 16-week initial treatment can switch to a maintenance dose of 250 mg administered every four weeks, providing a convenient first-line treatment option.

The approval was based on data from three phase 3 clinical trials—ADvocate-1, ADvocate-2, and ADhere—which involved 1,062 adults and adolescents with moderate-to-severe atopic dermatitis.

In ADvocate-1 and ADvocate-2, which assessed monotherapy use, Ebglyss showed significant improvements compared to placebo over 16 weeks. The EASI-75 (Eczema Area and Severity Index 75) response rates were 58.8 percent and 52.1 percent for the Ebglyss groups, compared to 16.2 percent and 18.1 percent for the placebo groups. The EASI-90 response rates were 38.3 percent and 30.7 percent for Ebglyss, compared to 9 percent and 9.5 percent for placebo.

After 52 weeks of maintenance therapy, the EASI-75 response rate in the Ebglyss group rose to 81.7 percent compared to 66.4 percent in the placebo group. The EASI-90 response rate reached 66.4 percent compared to 41.9 percent for placebo, confirming long-term improvement.

Common adverse events included conjunctivitis (6.9 percent), injection site reactions (2.6 percent), allergic conjunctivitis (1.8 percent), and dry eye (1.4 percent). Most adverse events were mild to moderate and did not lead to treatment discontinuation. The safety profile remained consistent after one year of treatment.