US pharmaceutical firm AbbVie (NYSE: ABBV) has announced receiving market approval from the National Medical Products Administration (NMPA) for its Rinvoq (upadacitinib), a selective JAK inhibitor, to treat moderate to severe active Crohn’s disease in adult patients who have a poor or intolerant response or a contraindication to one or more tumor necrosis factor (TNF) inhibitors.
Clinical Trial Support and Efficacy
The approval is supported by the successful results of the induction U-EXCEED and U-EXCEL studies and the U-ENDURE maintenance study, all of which reached common primary endpoints and key secondary endpoints. Compared to the placebo, Rinvoq demonstrated statistical significance in efficacy. The safety characteristics observed in patients with Crohn’s disease treated with Rinvoq were consistent with the known safety profile of the drug for other indications.
Rinvoque’s Global and Chinese Indications
Rinvoque was first approved in the US in 2019 and received approval in China in 2022. To date, it has received five indication approvals in China, including:
① Adults and children aged 12 years and above with refractory, moderate to severe atopic dermatitis who have a poor response to other systemic therapies or are not suitable for these treatments;
② Adult patients with moderate to severe active rheumatoid arthritis who have a poor or intolerant response to one or more TNF inhibitors;
③ Active psoriatic arthritis in adult patients with a poor or intolerant response to one or more DMARDs;
④ Adult patients with moderate to severe active ulcerative colitis (UC) who have a poor response to one or more TNF inhibitors or who are intolerant or contraindicated;
⑤ Adult patients with moderate to severe active Crohn’s disease who have a poor, intolerant, or contraindicated response to one or more TNF inhibitors.-Fineline Info & Tech
