European Commission Approves EBGLYSS (Lebrikizumab) for Moderate-to-severe AD

November 17, 2023

Almirall will first start the commercial launch in Germany and continue the rollout in further European countries throughout 2024. 

The European Commission has approved EBGLYSS (lebrikizumab) for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy. 

Almirall will first start the commercial launch in Germany and continue the rollout in further European countries throughout 2024. 

“The approval of lebrikizumab represents a leap forward in our ability to provide patients with an effective therapeutic option with demonstrated safety profile,” says Stephan Weidinger, MD, Ph.D. 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 news release. “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,” 

The approval is based on three pivotal Phase 3 studies including ADvocate 1 and ADvocate 2, evaluating lebrikizumab as monotherapy, and ADhere, assessing lebrikizumab in combination with topical corticosteroids (TCS), in adult and adolescent patients with moderate-to-severe atopic dermatitis. Lebrikizumab demonstrated early clinical efficacy in monotherapy at week 16, reducing disease extent and severity by at least 75% (EASI-75) in almost 6 out of 10 patients. In combination with topical corticosteroids, this was achieved in almost 7 out of 10 patients. Nearly 80% of Week 16 responders* who continued treatment with lebrikizumab both as monotherapy and in combination with TCS for up to two years experienced sustained skin clearance, itch relief and reduced disease severity with monthly maintenance dosing.

The Phase 3 clinical development program also evaluated the safety profile of lebrikizumab. Most adverse events (AE) across the studies were mild or moderate in severity and did not lead to treatment discontinuation. The most common adverse reactions were conjunctivitis, injection site reactions, allergic conjunctivitis, and dry eye.

Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in Europe. Eli Lilly and Company has exclusive rights for the development and commercialization of the product in the United States and the rest of the world, not including Europe.  The U.S. Food and Drug Administration (FDA) declived to approve lebrikizumab for AD due to certain findings during an inspection of a contract manufacturer in October 2023.

Almirall expects regulatory decisions for lebrikizumab in moderate-to-severe atopic dermatitis in additional European markets, including the United Kingdom and Switzerland.

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