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

▎WuXi AppTec Content Team Report

On October 27, AbbVie announced that the National Medical Products Administration (NMPA) of ChinaHas been approved itsJAK InhibitorRinvoq (Upadacitinib Extended-Release Tablets) Two New Indications, respectively, for those who respond poorly to non-steroidal anti-inflammatory drugs (NSAIDs) and exhibit objective signs of inflammation.Active Radiographic Negative Axial Spondyloarthritis (nr-axSpA)Adult patients, as well asWith an inadequate response or intolerance to one or more TNF inhibitorsActive Ankylosing Spondylitis (AS)Adult patients.According to the press release from AbbVie, the approval by the NMPA marks the Upadacitinib Extended-Release TabletsBecoming China's First Oral Targeted Drug Covering the Entire Course of Axial Spondyloarthritis (axSpA)。

AxSpA is a chronic inflammatory rheumatic disease that affects the spine and sacroiliac joints, including non-radiographic axial spondyloarthritis and radiographic axial spondyloarthritis, the latter of which is also known as ankylosing spondylitis (AS). Nr-axSpA is a chronic, progressive inflammatory rheumatic disease that can cause joint inflammation, leading to back pain and stiffness, and cannot be detected by X-ray examination. AS, on the other hand, is a chronic inflammatory musculoskeletal disease that primarily affects the spine, characterized by symptoms such as inflammatory back pain, stiffness, and restricted mobility. It is estimated that 10%-40% of nr-axSpA patients will progress to AS within 2-10 years.

Upadacitinib sustained-release tablets are a selective JAK inhibitor, currently under investigation by researchers for several immune-mediated diseases.Based on enzyme and cell experiments, this product exhibits 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 various indications, covering atopic dermatitis, rheumatoid arthritis, active psoriatic arthritis, ulcerative colitis, and Crohn's disease.。

This NMPA approval is for the use of Upadacitinib Extended-Release Tablets in the treatment of nr-axSpA.Indications, based on data from the Phase 3 SELECT-AXIS 2 (Study 2) clinical trial. This study evaluated the efficacy, safety, and tolerability of the product in adult patients with active nr-axSpA. The results showed that, compared with placebo, in patients receiving upadacitinib extended-release tablets 15mg,Nearly half of the patients achieved ASAS40 response (primary endpoint) at week 14 (44.9% vs. 22.3%, respectively).In nr-axSpA patients treated with upadacitinib sustained-release tablets, an ASAS40 response was observed as early as two weeks.

This time, Upadacitinib Sustained-Release TabletsThe approval of AS indications is based on the efficacy and safety data from the Phase 3 SELECT-AXIS 2 clinical trial (Study 1).. This part of the trial enrolledAS patients who have an inadequate response or are intolerant to one or two biological disease-modifying antirheumatic drugs (bDMARDs).The results showed that at week 14, compared with placebo,Upadacitinib Sustained-Release Tablets 15mg Improve Patients' Signs and Symptoms, including total back pain, physical function, and disease activity.

Director of the National Clinical Research Center for Skin and Immune Diseases, Department of Rheumatology and Immunology, Peking Union Medical College Hospital, Principal Investigator of SELECT-AXIS 2 StudyProfessor Zeng XiaofengSaid: "Many patients with nr-axSpA continue to experience symptoms, and current treatments are unable to control the disease, which may progress to AS. In the SELECT-AXIS 2 trial, upadacitinib demonstrated efficacy in treating both nr-axSpA and AS, with a consistent safety profile across indications. Today, the approval by the National Medical Products Administration (NMPA) provides an important new treatment option for patients and their caregivers to help manage their symptoms and disease."

Vice President of AbbVie and General Manager of AbbVie ChinaMs. Dong Lijun"Noted: 'Radiographic-negative axial spondyloarthritis and ankylosing spondylitis are diseases that can cause persistent structural damage, with a higher incidence in younger populations. If left untreated, patients may face the risk of 'body stiffness,' where they could become unable to move any part of their body except for internal organs. As the first oral targeted drug covering the entire course of axial spondyloarthritis, Riff will be dedicated to improving disease activity and quality of life for these patients. The recent approval of Riff's two major indications in China once again demonstrates our commitment to continuously advancing the standard treatment of rheumatic immune diseases, providing innovative directions for the treatment of Chinese patients with rheumatic immune diseases.'"

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