AbbVie’s JAK Inhibitor Upadacitinib Oral Solution Granted Two INDs in China for Pediatric Atopic Dermatitis

Screenshot source: CDEOfficial Website

The JAK family is a class of non-receptor tyrosine kinases, including four subtypes: JAK1, JAK2, JAK3, and TYK2. They play important roles in the signal cascades of various type I and type II cytokine receptors. The signaling pathways mediated by JAK are associated with processes such as cell proliferation, differentiation, apoptosis, and inflammation.

Upadacitinib is a selective JAK inhibitor. Earlier studies have shown that this product exhibits greater inhibitory potency against JAK1 than against JAK2, JAK3, and TYK2. In China, upadacitinibSustained-release TabletsIt has previously been approved for the treatment of various indications, covering atopic dermatitis, rheumatoid arthritis, active psoriatic arthritis, ulcerative colitis, Crohn's disease, active radiographic-negative axial spondyloarthritis (nr-axSpA), and active ankylosing spondylitis (AS), among others.

Among them, forAtopic DermatitisIndications: Upadacitinib Extended-Release Tablets were approved for marketing in China in February 2022, for adult and adolescent patients aged 12 years and above with moderate to severe atopic dermatitis. Notably, in April this year, AbbVie announced the results of the Phase 3b/4 LEVEL UP head-to-head study of upadacitinib in adult and adolescent patients aged 12 years and above with moderate to severe atopic dermatitis (AD). The study showed that at week 16, the proportion of patients achieving both a 90% or greater reduction in the Eczema Area and Severity Index (EASI 90) and a Worst Pruritus Numerical Rating Scale score of 0 or 1 (WP-NRS 0/1) was significantly higher with upadacitinib (19.9% for upadacitinib vs. 8.9% for the control drug IL-4/IL-13 inhibitor).

According to the official website of the Chinese Clinical Trial Registry and Information Disclosure Platform, AbbVie is conducting an international multicenter (including China) Phase 3 clinical study to evaluate in subjects aged 1 to <18 with active systemic juvenile idiopathic arthritis.OralUpadacitinibEfficacy, safety, and pharmacokinetic characteristics compared with the tocilizumab control group.

This time, UpadacitinibOral SolutionApproved for clinical trials, targeting moderate to severe atopic dermatitis in children aged 2 to under 12. This means the oral solution formulation of this innovative product will initiate clinical research for a new patient population.

References:

[1] Center for Drug Evaluation, National Medical Products Administration of ChinaWebsite. Retrieved Aug 20, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2] LEVEL UP Study Yields Positive Results: Upadacitinib Outperforms Dupilumab in Primary and All Secondary Endpoints. . Retrieved Apr 26 , 2024, from https://mp.weixin.qq.com/s/10Thvf6jIVXmhyF5wjKDzg