Eli Lilly's IL-13 Inhibitor Lebrikizumab Granted Clinical Trial Approval in China for Moderate-to-Severe Atopic Dermatitis

Dec 18, 2023 08:20 CST Updated 08:20

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The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that the lebrikizumab injection submitted by Eli Lilly and Company has obtained tacit approval for clinical trials, intended for development to treatAdolescents (12 years and older, weighing at least 40kg) and adult patients with moderate to severe atopic dermatitis (AD). Public information shows that this isDeveloped jointly by Almirall and Eli Lilly and CompanyIL-13 Specific Antibody Therapy, which has already been granted the world's first approval in the EU this November for use inAdolescents and AdultsPatients with Moderate to Severe Atopic Dermatitis。

Screenshot source: CDE official website

IL-13 is a key cytokine in atopic dermatitis, driving type 2 inflammatory responses in the skin.This reaction leads to impaired skin barrier function, itching, skin thickening, and infection.Lebrikizumab is a monoclonal antibody that binds to IL-13 with high affinity, effectively preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signal transduction.. This inhibition significantly mitigates the biological effects of IL-13. The product has demonstrated both short-term and long-term efficacy and safety, with a maintenance dose required once per month, providingProvides a new treatment option for patients with moderate to severe atopic dermatitis who are unresponsive to localized treatments.。

In November this year,Almirall AnnouncesLebrikizumab Receives European Commission ApprovalApproved for Marketing, for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis.Public information shows,Almirall has the rights to develop and commercialize lebrikizumab in Europe for the treatment of dermatological conditions, including atopic dermatitis.Eli Lilly and Company has exclusive development and commercialization rights in all regions outside of Europe.

It is reported that,The approval of ebrikizumab is based on three pivotal Phase 3 clinical studies, with the ADvocate 1 and ADvocate 2 studies evaluating its efficacy as monotherapy, and the ADhere study assessing its effects in combination with topical corticosteroids (TCS).At Week 16,Lebrikizumab demonstrated early clinical efficacy as monotherapy, with over 50% of patients achieving at least a 75% reduction in disease extent and severity (EASI-75).。When used in combination with TCS, this effectiveness increased to nearly 70% of patients.

In addition, earlierLong-term Extension StudyDisplay,Achieved remission at Week 16 andPatients who continued to receive lebrikizumab treatment, either as monotherapy or in combination with TCS,Nearly 80% of patients can maintain clear skin, itch relief, and reduced disease severity for up to two years.

References:

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Dec 15, 2023, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] Almirall Receives European Commission Approval of EBGLYSS® (lebrikizumab) for Moderate-to-Severe Atopic Dermatitis. Retrieved November 17, 2023, from https://www.businesswire.com/news/home/20231116347732/en

[3] Napolitano et al., (2023). The hidden sentinel of the skin: An overview on the role of interleukin-13 in atopic dermatitis. Frontiers in Medicine, https://doi.org/10.3389/fmed.2023.1165098

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