Pharmaceutical Executive June 19, 2024
Don Tracy, Associate Editor

Approval of Skyrizi marks the first IL-23 specific inhibitor approved for both ulcerative colitis and Crohn disease of similar severity, according to AbbVie.

The FDA has approved AbbVie’s Skyrizi (risankizumab-rzaa) for the treatment for adults with moderately to severely active ulcerative colitis (UC). According to the company, this approval makes Skyrizi the first IL-23 specific inhibitor to be approved for both UC and Crohn disease classified as moderate-to-severe. The approval was based on results from the INSPIRE Induction study and the COMMAND Maintenance study. In addition to the approved indications for UC and Crohn disease, Skyrizi also has been approved for active psoriatic arthritis and plaque psoriasis.1

“When treating patients with ulcerative colitis, it’s important to prioritize both early and...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
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