AbbVie’s interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab-rzaa) has been approved by the US Food and Drug Administration (FDA) to treat adults with moderately to severely active ulcerative colitis (UC).
Affecting more than one million people in the US, 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 an urgency to use the bathroom, and the disease can, in some cases, lead to complications such as cancer.
Skyrizi works by selectively blocking IL-23, a cytokine thought to be linked to a number of chronic immune-mediated diseases, and is already approved in the US to treat plaque psoriasis, psoriatic arthritis and Crohn’s disease.
The dosing regimen for Skyrizi in UC includes a 12-week induction period of three 1200mg doses given every four weeks, followed by doses of 180mg or 360mg delivered every eight weeks. Following the induction period, patients can administer the therapy at home using an on-body injector.
The FDA’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 the key secondary endpoint of endoscopic improvement.
“When treating patients with UC, it’s important to prioritise both early and sustained clinical remission as well as endoscopic improvement,” said Edward Loftus, the division of gastroenterology and hepatology at Mayo Clinic in Rochester, US. “This approval for Skyrizi is an important step toward addressing these treatment goals.”
The authorisation comes just days after AbbVie and FutureGen Biopharmaceutical announced a licence agreement worth $1.7bn to develop a pre-clinical therapy for IBD.
The deal gives AbbVie an exclusive global licence to develop, manufacture and commercialise the candidate, FG-M701, which is hoped to offer greater efficacy and less frequent dosing for patients.