US giant AbbVie (NYSE: ABBV) announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its Skyrizi (risankizumab). The drug is approved to treat adult patients with moderate to severe active Crohn’s disease who have insufficient response, loss of response, or intolerance to traditional or biologic treatments. The approval covers both Skyrizi injection and subcutaneous injection formats.
Clinical Achievements
Skyrizi, the world’s first interleukin-23 (IL-23) inhibitor for moderate to severe active Crohn’s disease, has demonstrated significant improvements in endoscopic response and clinical remission. Results from the induction clinical studies (ADVANCE and MOTIVATE) and the maintenance therapy clinical study (FORTIFY) highlight its efficacy in managing this chronic inflammatory condition.
Market and Patient Impact
The approval of Skyrizi in China marks a crucial step forward in the treatment landscape for Crohn’s disease, offering a new therapeutic option for patients with unmet needs. By targeting the IL-23 pathway, Skyrizi addresses the underlying inflammation driving the disease, potentially improving quality of life for many patients.-Fineline Info & Tech
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