US-based pharmaceutical company AbbVie (NYSE: ABBV) has announced the receipt of two additional indication approvals from China’s National Medical Products Administration (NMPA) for its drug Rinvoq (upadacitinib). The selective JAK inhibitor is now approved for treating adult patients with active radiologically negative axial spinal arthritis (axSpA) who show a poor response to non-steroidal anti-inflammatory drugs (NSAID) and exhibit objective inflammatory signs, as well as adult patients with active ankylosing spondylitis (AS) who have responded poorly or are intolerant to TNF inhibitor treatment.
Understanding AxSpA and AS
AxSpA is a chronic inflammatory rheumatic disease affecting the spine and iliac joints, encompassing both radiologically negative axial osteoarthritis (nr axSpA) and radiologically positive axial osteoarthritis, also known as ankylosing spondylitis (AS). This chronic and progressive condition can lead to joint inflammation, causing back pain and stiffness. It is estimated that 10%-40% of nr-axSpA cases may progress to AS within a 2-10 year period.
Phase III Study Results and Previous Approvals
The NMPA’s approvals are supported by positive data from the Phase III SELECT-AXIS 2 study, which demonstrated higher response levels in nr-axSpA and AS patients treated with Rinvoq compared to placebo. Initially approved in the US in 2019, Rinvoq has since been granted five indication approvals in China in 2022. These include treatments for refractory atopic dermatitis in adults and children aged 12 years and above, moderate to severe active rheumatoid arthritis, active psoriatic arthritis, moderate to severe active ulcerative colitis (UC), and moderate to severe active Crohn’s disease, particularly in patients who have shown poor response or intolerance to existing treatments.-Fineline Info & Tech
