FDA Approval of Lilly's EBGLYSS Provides New Treatment for Atopic Dermatitis
By approving EBGLYSS (lebrikizumab-lbkz), FDA has made available a new biologic treatment for moderate-to-severe atopic dermatitis that is not well controlled with topical treatments.
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On Sept. 13, 2024, FDA approved Eli Lilly and Company’s (Lilly’s) EBGLYSS (lebrikizumab-lbkz), a targeted interleukin 13 (IL-13) inhibitor, for treating moderate-to-severe atopic dermatitis (eczema) in adults and children 12 years of age and older. The treatment is applicable to patients who weigh at least 88 pounds (40 kg) and whose moderate-to-severe atopic dermatitis is not well controlled with topical prescription therapies.
FDA’s approval was based on results from several studies (ADvocate 1, ADvocate 2, and ADhere). These studies included more than 1000 adults and children (aged 12 and older) with moderate-to-severe eczema whose symptoms were not controlled with topical prescription medicines. At 16 weeks, the primary endpoint for these studies was evaluated; measurements showed clear or almost clear skin, according to the company press release.
"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, 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 (1), in a company press release. "[FDA’s] 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."
Averaging two of the studies (ADvocate 1 and 2), it was shown that 38% of people who underwent the treatment achieved clear or almost-clear skin at 16 weeks, compared to 12% with placebo. Ten percent saw the same results in as early as four weeks. Many responders also experienced itch relief in both studies with the treatment. On average, 43% felt itch relief at 16 weeks, compared to 12% on the placebo. Five percent of people felt relief as early as two weeks.
"Eczema can affect people of all skin tones, ethnicities, genders, and ages. Nearly 16.5 million adults in the [United States] have eczema, with 6.6 million experiencing moderate-to-severe symptoms [such as] itchiness, dry and scaly skin, discoloration, and rashes, which can lead to more scratching that may cause skin to crack and bleed, (2)” said Kristin Belleson, president and CEO of the National Eczema Association, in the release. "The approval of EBGLYSS provides hope and promise for the eczema community and those still seeking lasting relief from disruptive symptoms."
"People living with eczema have symptoms that can appear at the most inopportune times, creating unpredictability and impacting their everyday lives," said Daniel Skovronsky, MD, PhD, chief scientific officer and president of Lilly Research Laboratories, and president, Lilly Immunology, in the release. "Today's approval allows people the opportunity to reimagine life with eczema as EBGLYSS offers a targeted approach to reduce a main cause of eczema inflammation. EBGLYSS provides long-lasting symptom relief with a convenient once-monthly maintenance dose."
EBGLYSS was also approved in Europe by the European Commission in 2023 and in Japan in January 2024. Additional market approvals are expected later this year.
Lilly has exclusive rights for the development and commercialization of EBGLYSS in the US and the rest of the world outside Europe. Almirall, Lilly's partner, has licensed the rights to develop and commercialize the biologic for treating dermatology indications, including eczema, in Europe.
References
1. Silverberg, J. I.; Guttman-Yassky, E.; Thaçi, D.; et al. Two Phase 3 Trials of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis. N. Engl. J. Med. 2023, 388 (12),1080–1091. DOI: 10.1056/NEJMoa2206714
2. Chiesa Fuxench, Z. C.; Block, J. K.; Boguniewicz, M.; et al. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J. Invest. Dermatol. 2019, 139 (3), 583–590. DOI: 10.1016/j.jid.2018.08.028
Source: Eli Lilly and Company
