FDA Approves Risankizumab-rzaa for Crohn’s Disease Indication

The FDA approved risankizumab-rzaa (Skyrizi), an interleukin-23 antagonist, for the treatment of moderately to severely active Crohn’s disease in adults. Risankizumab-rzaa was previously approved for the treatment of plaque psoriasis and psoriatic arthritis. It is provided as an injection for subcutaneous or intravenous use. It is a product of AbbVie.

The approval was based on data from phase 3 studies that showed a greater proportion of patients treated with risankizumab-rzaa 600 mg met the efficacy end points versus placebo at week 12: clinical remission, endoscopic response, clinical response, and endoscopic remission. The onset of clinical response and clinical remission occurred as early as week 4 in a greater proportion of patients in the risankizumab-rzaa arm of the studies.

The most commonly reported adverse reactions with risankizumab-rzaa during maintenance treatment were arthralgia, injection-site reactions, abdominal pain, anemia, pyrexia, back pain, arthropathy, and urinary tract infections. Risankizumab-rzaa may cause serious side effects, including serious allergic reactions and infections.

AbbVie has a patient support program and co-pay card that may reduce out-of-pocket costs to as little as 5% per month for eligible, commercially insured patients, who may also be reimbursed for out-of-pocket costs related to intravenous administration. For those with limited or no health insurance, AbbVie offers a patient assistance program that provides the medication at no charge to those who qualify.

For full prescribing information, consult product labeling.