hapabapa The Food and Drug Administration (FDA) has approved AbbVie's ( NYSE: ABBV ) bid to market its bowel disease therapy Skyrizi for ulcerative colitis, making the drug available across four medical conditions in the U.S. The interleukin-23 (IL-23) inhibitor was previously approved in the U.
S. for adults with psoriatic arthritis, plaque psoriasis, and Crohn's disease. With the latest approval, Skyrizi, a potential replacement for AbbVie's ( ABBV ) blockbuster arthritis therapy Humira, will also be available for adults with moderate to severe ulcerative colitis.
The FDA's decision was supported by data from two Phase 3 clinical trials, INSPIRE and COMMAND. Both studies reached the primary endpoint of clinical remission and endoscopic improvement, a key secondary endpoint. Skyrizi, also known as risankizumab, is jointly developed and commercialized by AbbVie ( ABBV ) in partnership with German drugmaker Boehringer Ingelheim.
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