Almirl S.A. announced that the European Commission (EC) 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. The company will continue the rollout in further European countries throughout 2024.

Lebrikizumab is a monoclonal antibody that binds IL-13 with high affinity to specifically prevent the formation of the IL-13R1/IL-4R heterodimer complex and subsequent signalling, thereby inhibiting the biological effects of IL-13.(1-4) The cytokine IL-13 is key in atopic dermatitis, driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection. Lessrikizumab represents a significant step forward in patients with moderate-to-severe AD not controlled with topical therapy due to its selective mechanism of action, proven short and long-term efficacy and safety demonstrated up to 2 years(5-8) and a monthly maintenance dosing for all patients. Lebrikizumumab 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 expects regulatory decisions for lebrikizumab in moderate-to-severe atopopic dermatitis in additional European markets, including the United Kingdom and Switzerland.

Responders were defined as those achieving a 75% reduction in the Eczema Area and Severity Index from baseline (EASI- 75) or an IGA 0 or 1 ("clear" or "almost clear") with at least 2-point improvement and without rescue medication use at Week 16.