Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Ebglyss (lebrikizumab-lbkz) for the treatment of moderate-to-severe atopic dermatitis (eczema) in adults and children 12 years and older (weighing at least 88 pounds/40 kg) whose condition is not well controlled with topical prescription therapies. Ebglyss, a targeted IL-13 inhibitor, addresses eczema inflammation throughout the body, which leads to dry, itchy, and irritated skin.
Ebglyss is administered via a 250 mg/2 mL injection and can be used with or without topical corticosteroids. The recommended initial 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 when adequate clinical response is achieved. After this, maintenance dosing is a single monthly injection (250 mg every four weeks).
Clinical Trial Data
The FDA approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1,000 adults and children (aged 12 and older) with moderate-to-severe eczema who were unable to control their symptoms with topical prescription medicines. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA 0,1).
In the ADvocate 1 and 2 studies, an average of 38% of patients treated with Ebglyss achieved clear or almost-clear skin at 16 weeks, compared to 12% with placebo. 10% of patients saw these results as early as four weeks. Of those who achieved clear or almost-clear skin at Week 16, 77% maintained these results at one year with once-monthly dosing. 48% of responders who were switched from Ebglyss to placebo at Week 16 maintained these results at one year.
Similarly, the studies demonstrated itch relief with Ebglyss. On average, 43% of patients who took Ebglyss felt itch relief at 16 weeks, compared to 12% who took placebo. 5% felt relief as early as two weeks. Of the people who felt itch relief at Week 16, 85% still felt that relief at one year of treatment with monthly maintenance dosing. 66% of responders who were switched from Ebglyss to placebo at Week 16 maintained these results at one year.
Expert Commentary
"Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives," said Jonathan Silverberg, M.D., Ph.D., M.P.H., professor of dermatology at George Washington University School of Medicine and Health Sciences. "Today’s FDA approval of EBGLYSS is a big win for patients, as we now have a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions aren’t enough."
Disease Burden
Nearly 16.5 million adults in the U.S. have eczema, with 6.6 million experiencing moderate-to-severe symptoms like itchiness, dry and scaly skin, discoloration, and rashes, which can lead to more scratching that may cause skin to crack and bleed.
Safety and Availability
The most common side effects of Ebglyss include eye and eyelid inflammation, such as redness, swelling, and itching; injection site reactions; and shingles (herpes zoster). Ebglyss is contraindicated in people allergic to lebrikizumab-lbkz or any of the ingredients in Ebglyss.
Ebglyss will be available in the United States in the coming weeks. Lilly is committed to patient access and will offer a patient support program, including co-pay assistance for eligible, commercially insured patients, through Lilly Support Services for Ebglyss.
Ebglyss has also been approved for use by the European Commission in 2023 and in Japan in January 2024, with additional markets expected later this year.
