FDA Approves Lilly's EBGLYSS™ (lebrikizumab-lbkz) for Adults and Children 12 Years and Older with Moderate-to-Severe Atopic Dermatitis

EBGLYSS Approval and Efficacy - EBGLYSS, a targeted IL-13 inhibitor, has been approved by the FDA for the treatment of moderate-to-severe atopic dermatitis in adults and children aged 12 and older who weigh at least 40 kg [1] - Patients treated with EBGLYSS experienced significant skin clearance as early as four weeks and meaningful itch relief as early as two weeks [1] - In clinical trials, 38% of patients achieved clear or almost-clear skin at 16 weeks, compared to 12% with placebo, and 77% maintained these results at one year with monthly dosing [3] - 43% of patients experienced itch relief at 16 weeks, compared to 12% with placebo, and 85% maintained this relief at one year with monthly dosing [3] EBGLYSS Dosing and Administration - EBGLYSS is administered as a 250 mg/2 mL injection, with an initial dose of 500 mg at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16, then a single monthly maintenance dose [2] - The drug can be used with or without topical corticosteroids [2] Clinical Trials and Study Results - The approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1,000 patients with moderate-to-severe eczema [3] - The primary endpoint was clear or almost-clear skin (IGA 0,1) at 16 weeks, with key secondary endpoints including Eczema Area and Severity Index (EASI) and Pruritus Numeric Rating Scale [6][7] Market and Commercialization - EBGLYSS was approved by the European Commission in 2023 and in Japan in January 2024, with additional markets expected later this year [5] - Lilly has exclusive rights for development and commercialization of EBGLYSS in the U.S. and the rest of the world outside Europe, while Almirall S.A. holds rights in Europe [5] Patient Impact and Market Potential - Nearly 16.5 million adults in the U.S. have eczema, with 6.6 million experiencing moderate-to-severe symptoms [3] - EBGLYSS offers a new first-line biologic treatment option for patients who do not respond well to topical therapies [3] Mechanism of Action - EBGLYSS is a monoclonal antibody that selectively targets and neutralizes IL-13, a cytokine implicated in the pathophysiology of eczema [15] - The drug binds to IL-13 at an area overlapping with the IL-4Rα subunit, preventing receptor complex formation and inhibiting IL-13 signaling [15] Future Developments - Further data results from the ADmirable and ADapt studies are expected to be shared in 2024 and early 2025 [15]