AbbVie Inc. (ABBV) announced on Wednesday that the Food and Drug Administration (FDA) has granted approval for Skyrizi as a treatment for ulcerative colitis. This decision follows the outcomes of two Phase 3 clinical trials, INSPIRE and COMMAND, where the primary endpoint of clinical remission was successfully met, along with notable endoscopic improvement, a significant secondary endpoint.
Skyrizi is also approved in the United States for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn's disease.
