AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for adults suffering from moderately to severely active ulcerative colitis. This marks the first approval of an IL-23 specific inhibitor for both moderate to severe ulcerative colitis and Crohn's disease, broadening its application across immune-mediated inflammatory diseases.

Dr. Edward V. Loftus, Jr., a gastroenterology expert at Mayo Clinic, highlighted the importance of achieving both early and sustained remission and endoscopic improvement in the management of ulcerative colitis, noting the significance of this new approval.

In the United States, ulcerative colitis affects over 1 million individuals, often causing debilitating symptoms such as abdominal pain, bloody stools, and urgent bathroom needs, which can severely affect quality of life. The disease can also lead to significant complications, including the need for surgery or the development of cancer.

AbbVie commented that this approval enhances their range of treatments for inflammatory bowel disease (IBD) and underscores their dedication to meeting patient needs.

For the treatment of ulcerative colitis, SKYRIZI is administered over a 12-week induction period with three 1200 mg doses every four weeks, followed by maintenance therapy with either 180 mg or 360 mg every eight weeks. After the initial treatment phase, patients can continue their therapy at home using an on-body injector (OBI), designed for ease of use.

Patients with allergies to risankizumab-rzaa should avoid using SKYRIZI. Potential side effects include severe allergic reactions, infections, and liver issues, necessitating thorough medical consultation and monitoring. This medication is developed through a partnership between Boehringer Ingelheim and AbbVie.

AbbVie also provides support programs, such as co-pay cards and patient assistance, to help patients access SKYRIZI, especially those with limited health insurance coverage.

The clinical studies INSPIRE and COMMAND provide further details on the effectiveness and safety of SKYRIZI in treating ulcerative colitis.

SKYRIZI is an IL-23 inhibitor approved for treating moderate to severe ulcerative colitis, plaque psoriasis, psoriatic arthritis, and Crohn's disease, which selectively targets the IL-23 cytokine's p19 subunit involved in inflammatory processes. Complete safety and usage guidelines are available in the Medication Guide, with AbbVie offering resources for patients facing financial difficulties in accessing the medication.

 

Source: prnewswire.com

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