Eli Lilly's IL-13 Antibody Lebrikizumab (Ebglyss) Receives FDA Approval for Moderate-to-Severe Atopic Dermatitis

▎Armstrong

On September 13, 2024, Eli Lilly announced that the IL-13 antibody Lebrikizumab had been approved by the FDA for marketing. It is used to treat adult and pediatric patients aged 12 years and older with moderate to severe atopic dermatitis, under the brand name Ebglyss.

This approval was based on the Phase III clinical trials ADvocate 1 and ADvocate 2, with 16 weeks of treatment. Compared to the placebo group, IGA 0/1 increased by 30% and 22%, EASI-75 increased by 42% and 33%, and EASI-90 increased by 29% and 21%, respectively.

Efficacy data at 52 weeks are as follows.

In a cross-comparison, Ebglyss showed equivalent efficacy to Dupixent in treating atopic dermatitis (non-head-to-head).

Summary

Unlike the psoriasis market, which has seven blockbuster drugs, atopic dermatitis currently only has Dupixent as its sole blockbuster drug. Sanofi believes that the future trend of the atopic dermatitis market will be similar to that of psoriasis, where drugs with various mechanisms of action will drive the entire market to expand further, creating a flourishing and diverse landscape. Following Dupixent, Sanofi has also laid out plans for an OX40L antibody, IRAK4 PROTAC, IL-31, and a TSLP bispecific antibody.