2022-06-20| Trials & Approvals

AbbVie Scores First FDA Thumbs Up for Crohn’s Disease

by Fujie Tham
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AbbVie’s Skyrizi (risankizumab-rzaa) scored its third indication from the FDA, now approved to be the first and only specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderate to severe Crohn’s disease. 

The approval followed FDA evaluation of the ADVANCE, MOTIVATE, and FORTIFY studies, with significant improvements in endoscopic response and clinical remission versus placebo as early as week 4. Skyrizi is the first new treatment option in six years for moderately to severely active Crohn’s disease. It has been six years since the last Crohn’s disease treatment was approved by the FDA, Skyrizi will be a demanded alternative option for treating the disruptive symptoms of the disease.

This January, the medicine was approved by the FDA for treating adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints. These growing indications for Skyrizi are positioning the drug to be AbbVie’s flagship post-Humira strategy. 

Related article: The Next SuperStar Drug? AbbVie Places its Hope on Skyrizi and Rinvoq


Skyrizi’s Third Indication – Crohn’s disease


Crohn’s disease is a type of progressive inflammatory bowel disease (IBD). It causes inflammation of the digestive tract, which can then lead to persistent abdominal pain, severe diarrhea, fatigue, and malnutrition. Inflammation caused by Crohn’s disease can involve different areas of the digestive tract in different people, and often spreads into the deeper layers of the bowel. Because the signs and symptoms of the disease are unpredictable, it causes a significant burden on people living with the disease.

Skyrizi is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23 is thought to be linked to a number of chronic immune-mediated diseases, such as Crohn’s disease. Phase 3 trials of the therapeutic in psoriasis, ulcerative colitis, and psoriatic arthritis are ongoing. 

Besides Skyrizi, AbbVie is also actively advancing its Rinvoq, a JAK inhibitor mainly used for the medication of rheumatoid arthritis. Both drugs cover indications of Humira and are expected to generate sales of $15 billion in 2025. In Q1 2022, Skyrizi’s sales reached $940 million, an increase of more than 60% compared to the previous quarter.

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