Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved EBGLYSS™ (lebrikizumab-lbkz), an IL-13 inhibitor, for treating moderate-to-severe atopic dermatitis (eczema) in adults and children aged 12 and older who weigh at least 88 pounds (40 kg). This approval is intended for patients whose eczema remains uncontrolled despite using topical prescription treatments. Eczema is an inflammatory condition that affects the skin, leading to dry, itchy, and irritated skin. EBGLYSS targets inflammation beneath the skin, addressing the root cause of these symptoms.
EBGLYSS is administered as a 250 mg/2 mL injection and can be used alone or with topical corticosteroids. The recommended starting dose is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or later. Once an adequate clinical response is achieved, the maintenance dose is a single 250 mg injection every four weeks.
“Many patients with moderate-to-severe atopic dermatitis struggle to control their symptoms with current therapies, and severe itching can greatly affect their daily lives,” said Jonathan Silverberg, M.D., Ph.D., M.P.H., professor of dermatology at George Washington University. “The FDA approval of EBGLYSS offers a new first-line biologic treatment option when topical treatments are not enough.”
The FDA’s decision was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which involved over 1,000 patients aged 12 and older with moderate-to-severe eczema. At Week 16, 38% of patients treated with EBGLYSS achieved clear or almost clear skin, compared to 12% with placebo. Additionally, 10% of patients saw improvements as early as Week 4. Among those who achieved clear skin at Week 16, 77% maintained their results with monthly maintenance doses over one year.
Itch relief was also significant, with 43% of EBGLYSS-treated patients experiencing relief by Week 16, compared to 12% with placebo. Of those who experienced itch relief, 85% maintained the improvement with monthly maintenance doses over a year.
“Eczema affects people across all demographics, and nearly 6.6 million adults in the U.S. suffer from moderate-to-severe symptoms,” said Kristin Belleson, President and CEO of the National Eczema Association. “The approval of EBGLYSS brings hope to those who continue to seek long-lasting relief from this debilitating condition.”
Common side effects of EBGLYSS include inflammation of the eyes and eyelids, injection site reactions, and shingles (herpes zoster). The treatment is not recommended for individuals allergic to lebrikizumab-lbkz or any of its ingredients. The safety profile was consistent throughout multiple studies, including the 16-week maintenance period.
“People living with eczema often face unpredictable symptoms that affect their daily lives,” said Daniel Skovronsky, M.D., Ph.D., chief scientific officer and president of Lilly Research Laboratories. “EBGLYSS offers a targeted approach to address the underlying inflammation and provides long-lasting relief with convenient once-monthly dosing.”
EBGLYSS will be available in the U.S. in the coming weeks. Lilly is working with insurers and healthcare providers to ensure patient access to EBGLYSS, including co-pay assistance for eligible patients through the Lilly Support Services™ program.
EBGLYSS was also approved by the European Commission in 2023 and in Japan in January 2024, with further approvals expected in additional markets later this year. Lilly holds exclusive rights to develop and commercialize EBGLYSS outside of Europe, while its partner Almirall S.A. manages the product’s development and commercialization in Europe.
