APPROVAL has been granted by the FDA for lebrikizumab-lbkz in treating moderate to severe atopic dermatitis (AD) in patients aged 12 and older. This IL-13 inhibitor is designed for individuals who haven’t responded adequately to topical therapies, including pediatric patients weighing at least 88 pounds. The approval is supported by data from major studies, ADvocate 1, ADvocate 2, and Adhere, which have involved more than 1,000 patients with uncontrolled eczema.
After 16 weeks, 38% of patients achieved clear or almost clear skin, compared to 12% of placebo users. Notably, 10% of patients saw improvement as early as 4 weeks. Among those who cleared at week 16, 77% maintained their results with monthly dosing, and 48% sustained clear skin even after transitioning to placebo.
Lebrikizumab also showed promising results in relieving itch. At 16 weeks, 43% of users experienced itch relief compared to 12% with placebo, with some feeling relief within 2 weeks. Among responders, 85% maintained relief with monthly treatment, and 66% continued to benefit after switching to placebo.
“This approval is a significant win for patients, offering a first-line biologic option when topical therapies are insufficient,” said Jonathan Silverberg, Associate Professor of Dermatology at The George Washington University School of Medicine and Health Sciences in Washington, DC and a key investigator in the clinical trials.
Lebrikizumab is expected to be available in the US within weeks, administered as a 250 mg/2 mL injection, either alone or with topical corticosteroids. Its approval adds a much-needed option for patients struggling with severe AD who seek longer-lasting relief.
Reference: Eli Lilly and Company. FDA Approves Lilly’s EBGLYSS™ (lebrikizumab-lbkz) for Adults and Children 12 Years and Older with Moderate-to-Severe Atopic Dermatitis. 2024. Available at: https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and#:~:text=INDIANAPOLIS%20%2C%20Sept.%2013%2C%202024,88%20pounds%20(40%20kg)%20with. Last accessed: September 17, 2024.
Anaya Malik | AMJ
