FDA approves AbbVie’s Skyrizi for UC treatment
Betsy Goodfellow | June 20, 2024 | News story | Medical Communications | AbbVie, FDA, Gastrointestinal tract, UC, ibd
AbbVie has announced that the US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), making it the first IL-23 specific inhibitor approved for both moderate to severe UC and moderate to severe Crohn’s disease.
The drug is now approved for four indications spanning various immune-mediated inflammatory diseases.
The dosing schedule for Skyrizi for this indication includes a 12-week induction period comprising three 1,200mg doses delivered every four weeks, then maintenance therapy of either 180mg or 360mg delivered every eight weeks. After this induction period, treatment with Skyrizi can be maintained at home with an on-body injection (OBI), a hands-free device designed to adhere to the body, taking approximately five minutes to deliver the medication following preparatory steps.
Edward V Loftus Jr MD, Maxine and Jack Zarrow Family professor of Gastroenterology in the division of gastroenterology and hepatology at the Mayo Clinic in Minnesota, US, stated: “When treating patients with UC, it’s important to prioritise both early and sustained clinical remission as well as endoscopic improvement. This approval for Skyrizi is an important step toward addressing these treatment goals.”
Roopal Thakkar MD, senior vice president and chief medical officer of global therapeutics at AbbVie, commented: “Today’s approval of Skyrizi for UC expands our IBD portfolio and demonstrates our commitment to helping address ongoing needs of patients. We will continue to invest in transforming the treatment landscape and the lives of people suffering from lBD.”
Betsy Goodfellow
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