FDA Approves Ebglyss for Severe Atopic Dermatitis

On Wednesday, September 18, 2024, the U.S. Food and Drug Administration (FDA) granted approval for Ebglyss (lebrikizumab-lbkz), a new treatment designed for individuals aged 12 and older who suffer from moderate-to-severe atopic dermatitis. This condition, also known as eczema, often remains inadequately controlled by existing topical prescription therapies.

Ebglyss is a biologic therapy that functions as a targeted interleukin-13 inhibitor. It is administered through a 250-mg/2 mL injection and can be used alongside or without topical corticosteroids. The dosing regimen for Ebglyss begins with an initial phase that includes two 250-mg injections (totaling 500 mg) at week 0 and week 2. Following this initial phase, patients transition to a maintenance dose of 250 mg once a month. Between weeks 2 and 16, patients receive 250 mg every two weeks until an adequate clinical response is observed.

The FDA's approval was heavily supported by the outcomes of three clinical trials: ADvocate 1, ADvocate 2, and ADhere, which together included more than 1,000 participants. These studies demonstrated that Ebglyss significantly improved the condition of patients with atopic dermatitis. In the pooled results from ADvocate 1 and ADvocate 2, 38% of participants treated with Ebglyss achieved clear or almost-clear skin at the 16-week mark, in contrast to just 12% of those given a placebo. Remarkably, 10% of participants experienced these improvements as early as four weeks into the treatment.

In terms of long-term efficacy, 77% of participants who achieved clear or almost-clear skin by week 16 maintained these results at one year with a once-monthly dosing schedule. Additionally, 48% of those who switched from Ebglyss to a placebo at the 16-week mark maintained their clear or almost-clear skin condition at the one-year mark. Importantly, significant relief from itching was observed among Ebglyss users, with 43% reporting reduced itch at 16 weeks compared to 12% in the placebo group.

Dr. Jonathan Silverberg, M.D., Ph.D., from George Washington University and the lead author of a paper published in the New England Journal of Medicine summarizing the clinical trials for Ebglyss, emphasized the need for better treatment options. "Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies," Dr. Silverberg stated. "Many experience poor long-term disease control, and severe itch can significantly impact their daily lives."

The pharmaceutical company Eli Lilly received the FDA's approval for Ebglyss, marking a significant advancement in the treatment options available for atopic dermatitis sufferers.