On June 3, the CDE website showed that AbbVieRisankizumab (risankizumab,Skyrizi) Injection and its subcutaneous injection formulation new indication marketing application approval obtainedAccepted by the Center for Drug Evaluation of the National Medical Products Administration.
Skyrizi is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to the IL-23 p19 subunit. IL-23 is a cytokine involved in inflammatory processes and is considered to be associated with many chronic immune-mediated diseases.SkyriziEntered the global market for the first time in 2019, and has so far gained approval for five indications, includingPlaque Psoriasis, Psoriatic Arthritis, Crohn's Disease,Generalized Pustular Psoriasis and Erythrodermic Psoriasis. 2024,SkyriziAlso expected to gain FDA approval for new indications in ulcerative colitis.Since its launch, Skyrizi's sales have been growing in leaps and bounds, maintaining a high double-digit growth rate every year. At this growth rate, it is expected to generate revenue exceeding 10 billion US dollars in 2024. Of course, Skyrizi's booming development momentum is closely related to AbbVie's aggressive efforts. According to the PharmaCube database, AbbVie, as the sponsor and collaborator, is currently advancing nearly 60 clinical studies around risankizumab.By PharmaCubePharmaGoAccording to the database, AbbVie has registered seven clinical studies in China, aimed at treating adult active psoriatic arthritis, moderate to severe ulcerative colitis in adolescents aged 16 and above and adults, and Crohn's disease. Among them, the two Phase III studies for the treatment of Crohn's disease have been completed.July 2023,Lisocabtagene Maraleucel Submitted for Marketing Approval in China for the First Time, Indication Likely Crohn’s Disease; Currently Under Review, Expected to Be Approved for Launch This Year.Based on the progress of clinical trials, it is speculated that the new indication for this marketing application is ulcerative colitis.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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