Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Ebglyss (lebrikizumab-lbkz), a targeted IL-13 inhibitor, for the treatment of adults and children 12 years of age and older (weighing at least 88 pounds/40 kg) with moderate-to-severe atopic dermatitis (eczema) that is not adequately controlled with topical prescription therapies. Ebglyss works by targeting eczema inflammation throughout the body, which can lead to dry, itchy, and irritated skin.
Ebglyss is administered as 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 Results
The 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 whose symptoms were not controlled by 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 experienced 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, in both studies, many patients experienced 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 patients 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 in Washington, DC, and first author of the New England Journal of Medicine manuscript summarizing Ebglyss clinical trials. "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."
Safety and Availability
The most common side effects of Ebglyss include eye and eyelid inflammation (redness, swelling, itching), injection site reactions, and shingles (herpes zoster). Ebglyss is contraindicated in individuals allergic to lebrikizumab-lbkz or any of its ingredients. Ebglyss will be available in the United States in the coming weeks. Lilly is committed to ensuring patient access through support programs and collaboration with insurers and healthcare providers.
About Ebglyss
Ebglyss is a monoclonal antibody that selectively targets and neutralizes IL-13, a key cytokine implicated in the pathophysiology of eczema. By binding to IL-13, Ebglyss prevents the formation of the IL-13Rα1/IL-4Rα heterodimer receptor complex, thereby inhibiting IL-13 signaling.
