EBGLYSS is intended for patients aged 12 years and above who are candidates for systemic therapy.
The company plans to begin selling the product in Germany initially and will gradually introduce it in additional European countries by the end of next year.
Lebrikizumab is a monoclonal antibody, which binds IL-13 with high affinity for preventing the IL-13Rα1/IL-4Rα heterodimer complex formation and subsequent signalling, thereby suppressing the biological effects of IL-13.
The approval for lebrikizumab was based on data from three Phase III studies, including ADvocate I and ADvocate II that assessed lebrikizumab as monotherapy.
Adhere study evaluated lebrikizumab along with topical corticosteroids (TCS) to treat adult and adolescent patients with this condition.
Furthermore, the Phase III clinical development programme assessed the safety profile of lebrikizumab.
Almirall anticipates regulatory decisions for lebrikizumab in moderate-to-severe atopic dermatitis across more European countries, including Switzerland and the UK.
Almirall chief medical officer Dr Volker Koscielny said: “This regulatory milestone again highlights Almirall’s commitment to develop innovative treatments that can make a meaningful difference in the lives of people with skin diseases.”
The company has licensed the rights for the development and commercialisation of lebrikizumab to treat dermatological conditions, such as atopic dermatitis, in Europe.
Eli Lilly exclusively holds rights for these activities in the US and the remaining parts of the world, except Europe.