AbbVie has announced receipt of US Food and Drug Administration (FDA) approval for SKYRIZI (risankizumab-rzaa) to treat adult patients with moderately to severely active ulcerative colitis.
SKYRIZI is the first IL-23 inhibitor to receive approval for moderate to severe ulcerative colitis and Crohn's disease indications, broadening its therapeutic reach in inflammatory bowel disease (IBD).
The approved regimen for SKYRIZI offers an induction period of 12 weeks with three 1200mg doses administered every four weeks. Maintenance therapy is then prescribed at either 180mg or 360mg every eight weeks.
Post-induction, patients have the option to self-administer SKYRIZI at home using an on-body injector.
The approval is grounded in results from two pivotal Phase III clinical trials: INSPIRE and COMMAND, in moderate to severe ulcerative colitis patients.
INSPIRE was a randomised, multicentre, double-blind, placebo-controlled trial that focused on the safety and efficacy of a 1200mg intravenous dose of risankizumab, given every four weeks as induction therapy in people with active ulcerative colitis.
The COMMAND study was designed to evaluate the safety and efficacy of risankizumab at doses of 180mg or 360mg subcutaneously in adults with the same condition over 52 weeks as maintenance therapy.
Both trials met their primary endpoint of clinical remission and reported significant endoscopic improvement, a crucial secondary endpoint.
Risankizumab, marketed as SKYRIZI, is the product of a collaborative effort between Boehringer Ingelheim and AbbVie. AbbVie is responsible for the global commercialisation and further development of the therapy.
AbbVie global therapeutics senior vice-president and chief medical officer Roopal Thakkar stated: “The 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.”
The latest development comes after AbbVie entered into a licence agreement with FutureGen Biopharmaceutical to develop FG-M701 for IBD.
