FDA Approves Eli Lilly's Ebglyss (lebrikizumab) for Moderate-to-Severe Atopic Dermatitis
Key Insights
The FDA has approved Eli Lilly's Ebglyss (lebrikizumab) for treating moderate-to-severe atopic dermatitis (search) in adults and children 12 years and older when topical treatments are insufficient.
Ebglyss, a monoclonal antibody targeting IL-13 (search), offers a less frequent, once-monthly maintenance dosing schedule compared to existing biologics like Dupixent and Adbry.
Clinical trials demonstrated that 38% of patients achieved clear or almost-clear skin at 16 weeks with Ebglyss, and 77% maintained these results at one year with monthly dosing.
The FDA has approved Eli Lilly's Ebglyss (lebrikizumab) for the treatment of moderate-to-severe atopic dermatitis (search) (eczema (search)) in adults and children aged 12 years and older whose condition is not adequately controlled by topical prescription medications. This approval introduces a new biologic option with a less burdensome dosing schedule compared to some existing therapies.
Mechanism of Action and Clinical Efficacy
Ebglyss is a monoclonal antibody that selectively binds to IL-13 (search), a cytokine crucial in driving the inflammatory response in atopic dermatitis (search). By blocking IL-13, the drug helps to reduce the inflammation, itching, and skin dryness associated with the condition. The approval was based on data from two Phase 3 clinical trials, where 38% of participants treated with Ebglyss achieved clear or almost-clear skin at 16 weeks, compared to 12% in the placebo group. Furthermore, among those who achieved clear or almost-clear skin at week 16, 77% maintained these results at one year with once-monthly maintenance dosing.
Itch Relief and Dosing Schedule
In addition to improvements in skin clearance, Ebglyss also demonstrated significant itch relief. At 16 weeks, 43% of participants receiving Ebglyss reported itch relief compared to 12% in the placebo group. Of those who experienced itch relief at week 16, 85% continued to experience relief at one year with once-monthly maintenance dosing. This less frequent dosing regimen may offer a significant advantage for patients seeking to minimize the burden of treatment.
Current Treatment Landscape
Existing biologics targeting IL-13 (search), such as Sanofi and Regeneron's Dupixent (dupilumab) and LEO Pharma’s Adbry (tralokinumab), are already available for atopic dermatitis (search). Dupixent, which blocks both IL-4 and IL-13, is administered every other week. Adbry, similar to Ebglyss in targeting IL-13, also requires every-other-week injections following initial dosing. Ebglyss differentiates itself by offering a once-monthly maintenance dose after initial loading doses.
Safety and Availability
The most common side effects reported in clinical trials of Ebglyss included eye and eyelid inflammation, injection site reactions, and shingles. Eli Lilly anticipates that Ebglyss will be available in the U.S. in the coming weeks. The drug has already been approved in Europe and Japan. The initial FDA decision was delayed due to manufacturing inspection findings at a third-party facility, but these issues have since been resolved.