Lebrikizumab summary slide.pdf (184.85 kB)

Lebrikizumab: First Approval

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posted on 2024-02-25, 19:11 authored by Susan Keam

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Susan J. Keam is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.

Abstract

Lebrikizumab (Ebglyss®) is a subcutaneous recombinant humanized IgG4 anti-IL-13 monoclonal antibody developed by Almirall S.A. and Eli Lilly and Company for the treatment of atopic dermatitis (AD). In November 2023, lebrikizumab was approved in the EU for the treatment of moderate-to-severe AD in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy. In December 2023, lebrikizumab was approved in the UK for the same indication. Lebrikizumab is under regulatory review for the treatment of AD in the USA, Switzerland, Japan and Australia. This article summarizes the milestones in the development of lebrikizumab leading to this first approval for AD.