Almirall announced that its received marketing authorisation from the European Commission (EC) for 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 who are candidates for systemic therapy. Almirall will first launch Ebglyss® in Germany and continue distribution in other European countries in 2024. Almirall licensed the rights to develop and commercialise lebrikizumab in Europe for dermatology indications from Dermira in June 2019, which was acquired by Eli Lilly in January 2020. Eli Lilly has exclusive rights for Ebglyss’® development and commercialisation in all other jurisdictions outside of Europe.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Ebglyss® to treat moderate and severe forms of atopic dermatitis in adults and adolescents.