Skyrizi snags FDA approval for moderate to severe UC; first IL-23 approved for UC, CD
Click Here to Manage Email Alerts
The FDA has approved Skyrizi for the treatment of adult patients with moderate to severe ulcerative colitis, making it the first interleukin-23 specific inhibitor approved for both UC and Crohn’s disease, AbbVie reported.
Skyrizi (risankizumab, AbbVie) is now approved for four indications across immune-mediated inflammatory diseases, including IBD, plaque psoriasis and psoriatic arthritis, according to a company press release.
“The FDA approval of Skyrizi for ulcerative colitis is a significant step forward in IBD patient care, providing a new avenue for patients to not only manage their symptoms, but also potentially achieve early and sustained clinical remission and endoscopic improvement,” Edward V. Loftus Jr., MD, Maxine and Jack Zarrow Family Professor of Gastroenterology in the division of gastroenterology and hepatology at Mayo Clinic, told Healio. “For patients who have faced the challenges of this disease, whether they have previous experience with advanced therapies or are newly seeking treatment, this approval provides a safe and effective option for managing their condition.”
The agency based its approval on results from the 12-week INSPIRE induction study and the 52-week COMMAND maintenance study, in which risankizumab achieved the primary endpoint of clinical remission, as well a key secondary endpoint of endoscopic improvement.
As Healio previously reported, key results from the INSPIRE study showed 20.3% of patients who received IV risankizumab 1,200 mg achieved clinical remission compared with 6.2% of those who received placebo (P < 0.00001). Further, a greater proportion of treated patients achieved endoscopic improvement (36.5% vs. 12.1%; P < 0.00001) and endoscopic histologic mucosal improvement (24.5% vs. 7.7%; P < 0.00001) after 12 weeks.
In the COMMAND study, results demonstrated higher rates of clinical remission with risankizumab 180 mg (40.2%) or 360 mg (37.6%) vs. placebo (25.1%), for an adjusted treatment difference of 16.3% and 14.2%, respectively. Most treated patients maintained clinical remission (70.2% and 50% vs. 39.6%), while 39.6% and 37.1% (vs. 25.1%) achieved steroid-free clinical remission at week 52.
The approved dosing includes a 12-week induction period with three 1200 mg every 4 weeks followed by maintenance with 180 mg or 360 mg every 8 weeks. Treatment with risankizumab following induction can be continued at home with a hands-free on-body injector, the release said.
“Today’s approval of Skyrizi for ulcerative colitis expands our IBD portfolio and demonstrates our commitment to helping address ongoing needs of patients,” Roopal Thakkar, MD, AbbVie’s senior vice president and chief medical officer of global therapeutics, said in the release. “We will continue to invest in transforming the treatment landscape and the lives of people suffering from IBD.”
Read more about
Click Here to Manage Email Alerts