Approvals

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) and moderate to severe Crohn’s disease.

The drug is now approved for four indications spanning various immune-mediated inf lammatory 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 260mg 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.

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.”

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 approva l for Skyrizi is an important step toward addressing these treatment goals.”