Therapy Areas: Inflammatory Diseases
Almirall's lebrikizumab gains European Commission approval for moderate-to-severe atopic dermatitis
17 November 2023 -

Almirall S.A. (BME:ALM), a biopharmaceutical company focused on medical dermatology, announced on Friday that it has received approval from the European Commission for EBGLYSS (lebrikizumab) in treating adult and adolescent patients (12 years and older, body weight at least 40 kg) with moderate-to-severe atopic dermatitis (AD) requiring systemic therapy.

The commercial launch will begin in Germany, with a broader European rollout planned throughout 2024.

Lebrikizumab, a monoclonal antibody binding to IL-13 with high affinity, addresses the type-2 inflammatory loop in the skin associated with AD. Its mechanism inhibits IL-13 biological effects, presenting a selective and proven solution for moderate-to-severe AD unresponsive to topical therapy. The approval stems from three pivotal Phase 3 studies, ADvocate 1, ADvocate 2 and ADhere, which assessed lebrikizumab in various scenarios. Notably, the studies demonstrated early clinical efficacy in both monotherapy and combination with topical corticosteroids, achieving sustained skin clearance and reduced disease severity with monthly maintenance dosing for up to two years.

The safety profile of lebrikizumab, evaluated during the Phase 3 clinical development programme, revealed predominantly mild or moderate adverse events, with conjunctivitis, injection site reactions, allergic conjunctivitis and dry eye being the most common reactions.

Almirall holds licensing rights for lebrikizumab development and commercialisation in Europe, while pharmaceutical company Eli Lilly and Company (NYSE:LLY) has exclusive rights for development and commercialisation in the United States and the rest of the world outside Europe.