Eli Lilly Submits New Indication Application for Ixekizumab Injection in China, Targeting Radiographic Axial Spondyloarthritis

By | Pharma Insights

On September 23, the latest public notice from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) revealed that Eli Lilly and Company has submitted a marketing authorization application for a new indication of ixekizumab injection, which has been accepted. Ixekizumab is an interleukin-17A (IL-17A) inhibitor previously approved in China for the treatment of adult patients with moderate-to-severe plaque psoriasis. Based on clinical trial data for ixekizumab in China, the indication applied for in this submission is speculated to be radiographic axial spondyloarthritis.

Screenshot source: CDE official website

IL-17A is a naturally occurring cytokine involved in normal inflammatory and immune responses, and plays a critical role in the pathogenesis of plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.

Ixekizumab, developed by Eli Lilly and Company, selectively binds to IL-17A and inhibits its interaction with the IL-17 receptor. By inhibiting the IL-17 receptor-mediated signaling pathway, ixekizumab suppresses the release of proinflammatory cytokines and chemokines, thereby alleviating the symptoms of inflammatory diseases.

In the United States, ixekizumab was first approved by the FDA in March 2016. Currently, the drug has received FDA approval for the treatment of multiple conditions, including moderate-to-severe plaque psoriasis, adult patients with active psoriatic arthritis (PsA), ankylosing spondylitis, and patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, among others.

In China, ixekizumab was first approved in September 2019 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. According to CDE disclosures, this marks the second marketing authorization application for a new indication of ixekizumab in China.

According to publicly available information, in November 2019, ixekizumab received approval in China for a clinical trial targeting radiographic axial spondyloarthritis. According to the registration information on ClinicalTrials.gov, Eli Lilly is currently conducting a 16-week, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial aimed at evaluating the efficacy and safety of ixekizumab in Chinese patients with radiographic axial spondyloarthritis. Consequently, it is inferred that the indication for which the drug is currently seeking regulatory approval is likely radiographic axial spondyloarthritis.

Axial spondyloarthritis (axSpA) is a chronic, autoinflammatory disease that primarily affects the axial skeleton, encompassing two subtypes: radiographic axial spondyloarthritis (r-axSpA) and non-radiographic axial spondyloarthritis (nr-axSpA). Among them, radiographic axial spondyloarthritis, also known as ankylosing spondylitis (AS), is the primary form of axSpA. Ankylosing spondylitis is a spondyloarthritis affecting the sacroiliac joints and the spine, which may manifest as chronic inflammatory back pain, spinal stiffness, and impaired skeletal function and mobility.

References:

[1]Center for Drug Evaluation, National Medical Products Administration. Retrieved Sep 23, 2021, from https://www.cde.org.cn/main/xxgk/listpage/2f78f372d351c6851af7431c7710a731

[2]A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis. Retrieved Sep 23，2021, from https://clinicaltrials.gov/ct2/show/NCT04285229?term=ixekizumab&cntry=CN&draw=2&rank=2

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