Almirall announces EMA acceptance for filing of Marketing Authorization Application (MAA) for lebrikizumab in atopic dermatitis

• Approval in Europe is expected in the second half of 2023
• The EMA application is based on the analysis of Phase III studies ADvocate 1&2 and ADhere
• Atopic dermatitis (AD) is a chronic, inflammatory skin disease. Up to 4.4% of adults in EU are affected, the prevalence appears to have increased over the past decades^[1],[2]

BARCELONA, Oct. 28, 2022 /PRNewswire/ -- Almirall, S.A. (ALM), a global biopharmaceutical company focused on skin health, today announced that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for lebrikizumab for the treatment of moderate to severe atopic dermatitis.  

The MAA dossier filing is based on three pivotal  Phase III studies[*]: ADvocate 1 and ADvocate 2, evaluating lebrikizumab as monotherapy in adult and adolescent patients with moderate-to-severe AD, and ADhere, assessing lebrikizumab in combination with topical corticosteroids (TCS). In the maintenance phase of the two monotherapy trials (ADvocate 1&2), lebrikizumab provided robust and durable improvements in skin clearance and itch for patients who achieved a clinical response* at Week 16 through one year of treatment. Results also demonstrated efficacy with every four-week dosing —after a 16-week induction period with lebrikizumab every two weeks—was similar to the efficacy observed for every two-week dosing.

"Today marks the first step of the regulatory process in Europe of lebrikizumab, which we believe it has the potential to become a best-in-class treatment for atopic dermatitis. Upon approval by the EMA, patients with AD would have a new treatment option with a favourable safety and efficacy profile. At Almirall, we continue to work towards the market launch of this potential breakthrough treatment with the aim of fulfilling our purpose of improving patients' lives", stated Karl Ziegelbauer, Ph.D., Almirall's Chief Scientific Officer.

Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe. Eli Lilly and Company has exclusive rights for the development and commercialization of lebrikizumab in the United States and the rest of the world, not including Europe.

^*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 a 2-point improvement and without rescue medication use at Week 16. At Week 16, responders were re-randomized to lebrikizumab 250 mg every two weeks or four weeks or placebo for an additional 36 weeks.

[*] More information about the Phase III studies:  ADvocate 1: EudraCT Number 2019-002932-10; NCT04146363; ADvocate 2: EudraCT Number 2019-002933-12; NCT04178967; Adhere: EudraCT Number 2019-004300-34; NCT04250337
^[1] Barbarot et al, Allergy. 2018;1284–1293;
^[2] Nutten S. Ann Nutr Metab. 2015;66 Suppl 1:8-16

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