AbbVie’s Skyrizi (risankizumab-rzaa) has been approved by the European Commission (EC) to treat adults with moderately-to-severely active ulcerative colitis (UC).
The interleukin-23 inhibitor has been specifically authorised for use in patients who have had an inadequate response to, lost response to, or been intolerant to conventional or biologic therapy.
Estimated to affect five million people globally, UC is a type of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining.
Patients often experience a range of unpredictable symptoms, including abdominal pain, bloody stools and faecal urgency, and the disease can, in some cases, lead to serious complications such as cancer.
Skyrizi, which is already approved in the EU to treat Crohn’s disease, plaque psoriasis and psoriatic arthritis, is designed to block a cytokine thought to be linked to a number of chronic immune-mediated diseases.
The dosing regimen for the therapy in UC includes an induction period of three 1200mg intravenous doses given every four weeks, followed by doses of 180mg or 360mg delivered every eight weeks by subcutaneous injection.
The EC’s latest approval was based on positive results from two late-stage trials, including the INSPIRE study designed to evaluate the safety and efficacy of a 1200mg intravenous dose of Skyrizi given every four weeks as an induction therapy in patients with moderately to severely active UC.
Also supporting the regulator’s decision was the 52-week COMMAND study, which assessed 180mg or 360mg subcutaneous doses of Skyrizi as a maintenance therapy in adults with the same condition.
Both trials met their shared primary endpoint of clinical remission and achieved key secondary endpoints of endoscopic improvement, including mucosal healing and histologic endoscopic mucosal healing.
“These are important findings as mucosal healing goes beyond symptom management to restoration of the intestinal lining and is associated with improved long-term outcomes,” said INSPIRE trial investigator Edouard Louis, Liège University.
Roopal Thakkar, executive vice president, research and development, and chief scientific officer, AbbVie, added that the new approval “provides physicians with a new treatment option that is proven to help a wide range of patients with varying degrees of prior therapy use”.