FDA Approves Ebglyss for Moderate-to-Severe Atopic Dermatitis

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The FDA has approved Eli Lilly’s Ebglyss (lebrikizumab-lbkz) for the treatment of moderate-to-severe atopic dermatitis (eczema) in adults and children aged 12 years and older who weigh at least 88 lbs. According to the company, Ebglyss is a biologic therapy that specifically targets the interleukin (IL)-13 pathway for systemic inflammation, which is responsible for the dry, itchy, and irritated skin associated with eczema. The approval was based on positive results from the ADvocate 1, ADvocate 2, and ADhere clinical trials.¹

"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, MD, PhD, MPH, professor of dermatology, George Washington University School of Medicine and Health Sciences, Washington, DC, and first author of The New England Journal of Medicine manuscript summarizing EBGLYSS clinical trials, in a press release. "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."

ADvocate 1 and ADvocate 2 were 52-week randomized, double-blind, placebo-controlled, parallel-group, global, Phase III studies designed to evaluate Ebglyss as a monotherapy in patients with moderate-to-severe eczema. As part of the trials, patients received Ebglyss 500 mg initially and at two weeks, followed by 250 mg or placebo every two weeks. Those who achieved a clinical response after 16 weeks were then re-randomized to receive the treatment every two weeks or four weeks, or placebo for an additional 36 weeks. The primary endpoint of both studies was a reduction of at least two points based on an Investigator Global Assessment score from baseline at 16 weeks.

Adhere was a 16-week randomized, double-blind, placebo-controlled, parallel-group, global, Phase III study that evaluated the efficacy and safety of Ebglyss in combination with topical corticosteroids. The trial enrolled 211 patients with moderate-to-severe eczema whose symptoms were inadequately controlled by topical medications.

Results from the Advocate studies found that 38% of patients achieved clear or almost-clear skin at 16 weeks, compared to 12% on placebo. Additionally, 77% of patients who responded to treatment maintained these results for up to one year with monthly dosing. Further, 43% of patients experienced significant itch relief by week 16, compared to 12% on placebo, with 85% maintaining relief after one year of treatment.

Common adverse events (AEs) associated with Ebglyss included eye and eyelid inflammation, such as redness, swelling, and itching, injection site reactions, and shingles. Lilly warns against the use of Ebglyss in people allergic to lebrikizumab-lbkz or to any ingredients in the treatment. The safety profile during maintenance treatment was found to be consistent throughout multiple studies.¹

According to the Asthma and Allergy Foundation of America, atopic dermatitis occurs in 7.3% of adults in the US, with 40% of this group having moderate to severe symptoms.²

"Eczema can affect people of all skin tones, ethnicities, genders and ages. Nearly 16.5 million adults in the US 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," said Kristin Belleson, president, CEO, National Eczema Association, in the press release. "The approval of Ebglyss provides hope and promise for the eczema community and those still seeking lasting relief from disruptive symptoms."

References

1. FDA Approves Lilly's EBGLYSS™ (lebrikizumab-lbkz) for Adults and Children 12 Years and Older with Moderate-to-Severe Atopic Dermatitis. Lilly. September 13, 2024. Accessed September 16, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and

2. Atopic Dermatitis in America. AAFA. Accessed September 16, 2024. https://aafa.org/asthma-allergy-research/our-research/atopic-dermatitis-in-america/