Germany will be the first country where lebrikizumab will be available for prescription, with a subsequent rollout across European countries throughout 2024.
Almirall (BME: ALM), has received approval from the European Commission (EC) for lebrikizumab (Ebglyss), a monoclonal antibody designed for the treatment of moderate to severe atopic dermatitis (AD) in adult and adolescent patients 12 years and older. This approval marks a pivotal moment in the management of AD, offering a new therapeutic option for those who are candidates for systemic therapy.
Lebrikizumab's mechanism of action involves high-affinity binding to interleukin-13 (IL-13), selectively inhibiting its downstream signaling. The cytokine IL-13 plays a key role in the type-2 inflammatory loop in the skin, contributing to skin barrier dysfunction, itch, skin thickening, and infection. The approval follows positive results from three pivotal Phase 3 studies, namely ADvocate 1, ADvocate 2, and ADhere, evaluating lebrikizumab both as monotherapy and in combination with topical corticosteroids.
Notably, Germany will be the first country where lebrikizumab will be available for prescription, with a subsequent rollout across European countries throughout 2024.
Volker Koscielny, chief medical officer at Almirall, expressed confidence in lebrikizumab's potential to become a first-line biologic treatment. He emphasized the demonstrated short and long-term efficacy, monthly maintenance dosing, and consistent safety profile, highlighting the positive impact on the lives of those affected by AD.
“The arrival of novel biologic treatments is marking a new paradigm in the management of atopic dermatitis. The approval of lebrikizumab represents a leap forward in our ability to provide patients with an effective therapeutic option with demonstrated safety profile. For healthcare professionals, it opens the door to improve the management of the disease and create a meaningful impact in the lives of our atopic dermatitis patients, offering new hope and improved prospects for their wellbeing,” said Stephan Weidinger, MD, PhD, professor of dermatogenetics at the Christian-Albrechts-University and Vice-Head of the Department of Dermatology at the University Hospital Schleswig-Holstein, Campus Kiel, Germany, in a press release.
The Phase 3 clinical development program not only demonstrated lebrikizumab's efficacy but also assessed its safety profile. Most adverse events reported were mild or moderate in severity, and the common reactions included conjunctivitis, injection site reactions, allergic conjunctivitis, and dry eye.
Almirall's licensing agreement with Eli Lilly and Company grants exclusive rights for lebrikizumab's development and commercialization in the United States and the rest of the world, excluding Europe. Additional regulatory decisions for lebrikizumab in AD are anticipated in other European markets.
Almirall. Almirall receives European Commission approval of EBGLYSS® (lebrikizumab) for moderate-to-severe atopic dermatitis.Press release. Published online November 17, 2023. Accessed November 17, 2023. https://www.almirall.com/newsroom/news/almirall-receives-european-commission-approval-of-ebglyss-lebrikizumab-for-moderate-to-severe-atopic-dermatitis