AbbVie has received the US Food and Drug Administration (FDA) approval for Skyrizi (risankizumab-rzaa) to treat adults with moderately to severely active ulcerative colitis.
Skyrizi is a humanised monoclonal antibody that selectively blocks IL-23, a cytokine involved in inflammatory processes related to several chronic immune-mediated diseases.
The drug is a result of collaboration between AbbVie and Boehringer Ingelheim, with AbbVie leading the development and commercialization worldwide.
Skyrizi is already approved in the US for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn’s disease.
It is the first IL-23-specific inhibitor approved for both ulcerative colitis and Crohn’s disease and approved for four indications across immune-mediated inflammatory diseases.
Skyrizi is warned for causing serious side effects, including serious allergic reactions, an increased risk of infections, and liver problems in people who are allergic to the drug.
AbbVie global therapeutics senior vice president, and chief medical officer Roopal Thakkar said: “Today’s approval of SKYRIZI for ulcerative colitis 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.”
Skyrizi dosing indication includes a 12-week induction period with three 1200mg doses for four weeks, followed by maintenance therapy of either 180mg or 360mg every eight weeks.
After the induction period, the treatment can be maintained at home using an on-body injector (OBI), a hands-free device that takes only five minutes to deliver the medication.
The FDA approval is supported by results from two Phase 3 clinical trials of Skyrizi, INSPIRE and COMMAND, for the treatment of moderate to severe ulcerative colitis.
In the study, Skyrizi achieved clinical remission, the primary endpoint in both the induction and maintenance studies, along with endoscopic improvement, a key secondary endpoint.
Ulcerative colitis is a form of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining.
Patients with ulcerative colitis often experience several unpredictable symptoms, such as abdominal pain, bloody stool, and urgency to use the bathroom.
