With FDA Approval, Lilly's EBGLYSS Treats Atopic Dermatitis
FDA approved EBGLYSS (lebrikizumab-lbkz) for moderate-to-severe atopic dermatitis that is difficult to treat with topicals
On September 13, 2024, the FDA approved Eli Lilly and Company’s EBGLYSS (lebrikizumab-lbkz), a specific inhibitor of interleukin 13 (IL-13), for the treatment of moderate-to-severe atopic dermatitis (eczema) in adults and children aged 12 and older. This treatment is suitable for patients weighing a minimum of 88 pounds (40 kg) who have moderate-to-severe atopic dermatitis that is not effectively managed with topical prescription therapies.
The FDA approved it after looking at results from multiple studies, including ADvocate 1, ADvocate 2, and ADhere. These studies involved over 1000 adults and children (aged 12 and older) who had moderate-to-severe eczema and whose symptoms were not managed with topical prescription treatments. At 16 weeks, the main goal for these studies was assessed; results indicated clear or nearly clear skin, as stated in the company press release.
"Patients continue to find it challenging to manage their moderate-to-severe atopic dermatitis using the therapies that are currently available." “Many people struggle with long-term disease management, and intense itching can greatly affect their everyday activities,” stated Jonathan Silverberg, MD, PhD, a dermatology professor at George Washington University School of Medicine and Health Sciences in Washington, DC, and the lead author of the New England Journal of Medicine article summarizing the EBGLYSS clinical trials (1), in a company press release. "The approval of EBGLYSS is a significant achievement for patients, providing a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions fall short."
By looking at the results from two studies (ADvocate 1 and 2), we see that 38% of individuals who received the treatment had clear or nearly clear skin after 16 weeks, while only 12% of those who took the placebo experienced similar results. Some individuals experienced similar outcomes in just four weeks. In both studies, many responders found relief from itching with the treatment. At 16 weeks, 43% experienced relief from itching, while only 12% in the placebo group did. Some individuals experienced relief within just two weeks.
"Eczema can impact individuals regardless of their skin tone, ethnicity, gender, or age." Approximately 16.5 million adults in the United States have eczema, with 6.6 million facing moderate-to-severe symptoms like itchiness, dry and scaly skin, discoloration, and rashes. These symptoms can result in increased scratching, potentially causing the skin to crack and bleed, according to Kristin Belleson, president and CEO of the National Eczema Association, in the release. "The approval of EBGLYSS brings hope and promise to the eczema community and those looking for lasting relief from bothersome symptoms."
"Individuals with eczema experience symptoms that can arise unexpectedly, affecting their daily routines and overall quality of life," stated Daniel Skovronsky, MD, PhD, chief scientific officer and president of Lilly Research Laboratories, and president of Lilly Immunology, in the release. "Today's approval gives people a chance to rethink life with eczema, as EBGLYSS provides a focused method to lessen a primary cause of eczema inflammation." EBGLYSS offers effective symptom relief that lasts, with an easy-to-use once-a-month maintenance dose.
EBGLYSS received approval in Europe from the European Commission in 2023 and in Japan in January 2024. More market approvals are anticipated later this year.
Lilly holds the sole rights for developing and marketing EBGLYSS in the US and globally, excluding Europe. Almirall, in partnership with Lilly, has obtained the rights to develop and market the biologic for dermatological conditions, such as eczema, in Europe.
