AbbVie's Oral JAK1 Inhibitor Upadacitinib Granted Clinical Trial Approval in China for Severe Alopecia Areata

Recently, the CDE official website showed that the clinical trial application of AbbVie's key JAK1 inhibitor, Upadacitinib Tablets, for severe alopecia areata has received tacit approval.

Alopecia areata is an autoimmune disease characterized by non-scarring hair loss that can affect any area with hair. Research indicates that alopecia areata may originate from the activation of the JAK-STAT pathway, leading to the collapse of the hair follicle immune microenvironment and triggering autoimmune attacks on the hair follicles.

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.

In February 2022, Upadacitinib tablets were approved for marketing in China for the first time, indicated for the treatment of moderate to severe atopic dermatitis. In March of the same year, two new indications were approved: moderate to severe rheumatoid arthritis and active psoriatic arthritis. In February this year, the fourth indication for Upadacitinib tablets was approved for the treatment of moderate to severe active ulcerative colitis. In July, Upadacitinib tablets secured their fifth indication for the treatment of moderate to severe active Crohn's disease.

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.

Notably, Eli Lilly's JAK inhibitor Baricitinib was approved for marketing by the NMPA in March this year. It is indicated for the systemic treatment of severe alopecia areata in adults, becoming the first innovative targeted drug in China for the systemic treatment of severe alopecia areata.

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