AbbVie’s JAK Inhibitor Upadacitinib Receives NMPA Approval in China for Two New Indications in Axial Spondyloarthritis

Intelligent Finance APP learned on October 27 that AbbVie (ABBV.US) announced that the National Medical Products Administration (NMPA) of China has approved two new indications for its JAK inhibitor RINVOQ (upadacitinib extended-release tablets). These are intended for adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) and exhibit objective signs of inflammation, as well as adult patients with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF inhibitors. According to AbbVie's press release,NMPA Approval Marks Upadacitinib Extended-Release Tablets as the First Oral Targeted Drug in China to Cover the Entire Course of Axial Spondyloarthritis (axSpA).

It is reported that upadacitinib sustained-release tablets are a selective JAK inhibitor, which researchers are studying in several immune-mediated diseases. Based on enzyme and cell assays, the product demonstrates greater inhibitory potency against JAK1 than against JAK2, JAK3, and TYK2. In China, upadacitinib sustained-release tablets have previously been approved for the treatment of multiple indications, covering atopic dermatitis, rheumatoid arthritis, active psoriatic arthritis, ulcerative colitis, and Crohn's disease.

The NMPA approval of upadacitinib sustained-release tablets for the treatment of nr-axSpA is based on data from the Phase 3 SELECT-AXIS 2 (Study 2) clinical trial.

Meanwhile, the approval of the AS indication for upadacitinib sustained-release tablets was based on the efficacy and safety data from the Phase 3 SELECT-AXIS 2 clinical trial (Study 1).