SKYRIZI® Approved for Ulcerative Colitis Treatment by FDA

Highlights

The U.S. FDA has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis. This marks the first approval of an IL-23 inhibitor for both ulcerative colitis and Crohn's disease, expanding AbbVie's portfolio in inflammatory bowel diseases.

Approval and Clinical Trials

AbbVie's SKYRIZI® has been granted approval by the U.S. FDA following successful outcomes from two Phase 3 clinical trials. The trials, INSPIRE (induction) and COMMAND (maintenance), demonstrated achievement of clinical remission and endoscopic improvement among patients with moderate to severe ulcerative colitis.

Medical Community and Patient Impact

Dr. Edward V. Loftus, Jr., emphasized the significance of achieving clinical remission and endoscopic improvement in ulcerative colitis treatment, noting the approval of SKYRIZI® as a positive step toward meeting treatment goals.

Scope and Impact of Ulcerative Colitis

With over 1 million affected individuals in the U.S., ulcerative colitis continues to rise, causing inflammation in the digestive tract and potential complications. Symptoms include abdominal pain, bloody stool, and urgency, varying in severity among patients.

AbbVie's Commitment and Treatment Regimen

AbbVie's commitment to addressing patient needs is reflected in the approval of SKYRIZI® for ulcerative colitis, with dosing including an induction period and maintenance therapy, facilitated by an on-body injector designed for patient convenience.

Safety Considerations

SKYRIZI® is associated with potential serious side effects, including allergic reactions and increased susceptibility to infections, requiring careful monitoring by healthcare providers during treatment.

Data Source: https://news.abbvie.com/2024-06-18-U-S-FDA-Approves-SKYRIZI-R-risankizumab-rzaa-for-Ulcerative-Colitis,-Expanding-AbbVies-Portfolio-Across-Inflammatory-Bowel-Disease