FDA Approves SKYRIZI® (risankizumab-rzaa) for Ulcerative Colitis
AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis. This marks the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn’s disease. SKYRIZI now holds approval for four different indications within immune-mediated inflammatory diseases.
Edward V. Loftus, Jr., M.D., the Maxine and Jack Zarrow Family Professor of Gastroenterology at Mayo Clinic in Rochester, Minnesota, emphasized the importance of early and sustained clinical remission and endoscopic improvement in treating ulcerative colitis. He noted that the approval of SKYRIZI is a significant step towards achieving these treatment goals.
The United States has a large and growing population of over 1 million people living with ulcerative colitis, a type of inflammatory bowel disease (IBD) that causes inflammation and damage to the colon lining. Symptoms vary but can include abdominal pain, bloody stool, and an urgent need to use the bathroom. The disease can lead to serious complications, including surgery, cancer, or even death.
SKYRIZI's dosing regimen for ulcerative colitis starts with a 12-week induction period involving three 1200 mg doses administered every four weeks. This is followed by maintenance therapy with either 180 mg or 360 mg doses given every eight weeks. After the induction period, patients can use an on-body injector (OBI) for home treatment. The OBI is a hands-free device that adheres to the body and administers the medication in about five minutes after preparation.
Patients allergic to SKYRIZI should not use it. Serious side effects may include allergic reactions, increased risk of infections, and liver problems. If a serious allergic reaction occurs, discontinue use and seek emergency medical help. Before beginning treatment, doctors should screen for infections and tuberculosis. Patients should inform their doctors about any infections or symptoms and any planned or recent vaccinations. Liver issues may arise during treatment for Crohn’s disease or ulcerative colitis, potentially requiring hospitalization. Regular liver blood tests are necessary, and treatment may be halted if liver problems occur.
Risankizumab (SKYRIZI) is developed and commercialized globally through a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie taking the lead.
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