AbbVie's Upadacitinib Extended-Release Tablets Receive Fifth Indication Approval in China for Crohn’s Disease

On July 4, the National Medical Products Administration (NMPA) announced that AbbVie's JAK1 inhibitor upadacitinib sustained-release tablets (brand name: Rinvoq) have been approved for a new indication in China. The drug is indicated for the treatment of adult patients with moderate to severe active Crohn's disease who have had an inadequate response to, are intolerant to, or have contraindications to one or more tumor necrosis factor (TNF) inhibitors.

This is the fifth indication for which the product has been approved in China. Its therapeutic areas cover dermatology, rheumatology, and gastroenterology, with the latter including two indications: ulcerative colitis (UC) and Crohn's disease (CD).

This approval is supported by data from two induction studies (U-EXCEED and U-EXCEL) and the U-ENDURE maintenance study. Both the 45mg upadacitinib induction study and the 15mg and 30mg upadacitinib maintenance studies met the co-primary endpoints and key secondary endpoints, demonstrating statistical significance compared to placebo.

Upadacitinib is a selective JAK inhibitor currently under investigation for various immune-mediated diseases. Based on enzyme and cell assays, upadacitinib demonstrates greater inhibitory potency against JAK1 than against JAK2, JAK3, and TYK2. In August 2019, the product received its first FDA approval for marketing to treat moderate to severe rheumatoid arthritis, making it the world's first approved JAK1 inhibitor.

Currently, the approved indications for Upadacitinib Extended-Release Tablets globally include: moderate to severe active rheumatoid arthritis; active psoriatic arthritis; moderate to severe atopic dermatitis; active ankylosing spondylitis; moderate to severe ulcerative colitis; active non-radiographic axial spondyloarthritis; Crohn's disease.

In February 2022, Upadacitinib Extended-Release Tablets were approved for marketing in China for the first time to treat moderate to severe atopic dermatitis. A month later, it was also approved for moderate to severe rheumatoid arthritis. In April, Upadacitinib Extended-Release Tablets were again approved for a new indication to treat active psoriatic arthritis. Additionally, in February this year, the fourth indication of Upadacitinib Extended-Release Tablets was approved to treat moderate to severe active ulcerative colitis. In January this year, the sixth indication of Upadacitinib Extended-Release Tablets was submitted for marketing approval in China.

Since its launch, the sales of Upadacitinib have grown rapidly, with sales in 2019, 2020, 2021, and 2022 reaching $0.47 billion, $7.31 billion, $16.51 billion, and $25.22 billion respectively. AbbVie expects that the sales of Upadacitinib will exceed $75 billion by 2025.

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