乌帕替尼获批上市治疗中度至重度活动性溃疡性结肠炎！

Upadatinib is a selective JAK1 inhibitor discovered and developed by AbbVie. It has shown good efficacy in clinical trials for the treatment of various autoimmune diseases and inflammatory diseases. In March 2022, the U.S. Food and Drug Administration (FDA) approved Rinvoq (upatinib) for the treatment of adult patients with moderately to severely active ulcerative colitis who have an inadequate response to or are intolerant to one or more tumor necrosis factor (TNF) blockers.

A review of the approval history of Upatinib

On August 24, 2021, AbbVie announced that the European Commission (EC) approved the expanded indication of its oral JAK inhibitor upadatinib for the treatment of patients with moderate/severe atopic dermatitis.

On February 24, 2022, China’s National Medical Products Administration (NMPA) approved the marketing of upadatinib extended-release tablets. This approval marks the first indication of upadatinib approved in China. It is used for patients with refractory, moderate to severe atopic dermatitis in adults and adolescents aged 12 years and above who have responded poorly to other systemic treatments (such as hormones or biological agents) or are not suitable for the above treatments.

Upadatinib is currently approved for the treatment of rheumatoid arthritis, Crohn's disease, psoriatic arthritis, atopic dermatitis, ankylosing spondylitis, ulcerative colitis, etc.

Ulcerative colitis indication approved for phase 3 related clinical trials

The phase 3 study of ulcerative colitis is based on an 8-week induction treatment study period. The study will randomly assign patients with moderate to severe ulcerative colitis (UC) who have achieved a clinical response to receive treatment for 52 weeks. The study results showed that a significantly higher proportion of patients in the upadacitinib group achieved clinical remission compared with the placebo group. At week 52, the study achieved all study objectives including endoscopic improvement, histological endoscopic mucosal improvement, and corticosteroid-free clinical remission.

In the 15 mg treatment group, 49% of patients achieved endoscopic improvement, 35% of patients achieved histological endoscopic mucosal improvement, and 57% of patients achieved corticosteroid-free remission. In the 30 mg treatment group, 62% of patients achieved endoscopic improvement, 49% of patients achieved histological endoscopic mucosal improvement, and 68% of patients achieved corticosteroid-free remission. In comparison, only 14% of patients in the placebo group achieved endoscopic improvement, 12% achieved histological endoscopic mucosal improvement, and 22% achieved corticosteroid-free remission.

In summary, the therapeutic effect of upadatinib is very significant.

Original source:

https://news.abbvie.com/news/press-releases/rinvoq-upadacitinib-receives-fda-approval-for-treatment-adults-with-moderately-to-severely-active-ulcerative-colitis.htm

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.

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