AbbVie announced that it has submitted an application to the US Food and Drug Administration (FDA) seeking approval for risankizumab-rzaa (600 mg intravenous (IV) induction and 360 mg subcutaneous (SC) maintenance therapy), an interleukin-23 (IL-23) inhibitor, for the treatment of patients 16 years and older with moderate to severe Crohn's disease. The submission is supported by safety and efficacy data from three phase 3 studies – ADVANCE, MOTIVATE and FORTIFY.

"While there have been advancements in care, many people with Crohn's disease do not achieve lasting remission," said Tom Hudson, senior vice president of research and development, chief scientific officer, AbbVie. "This submission is an important step forward in our commitment to providing an additional treatment option for those who struggle with this debilitating and often unpredictable disease."

In the analysis plans for the US submission of the ADVANCE and MOTIVATE induction studies, a significantly greater proportion of patients with Crohn's disease treated with either dose of risankizumab-rzaa IV induction therapy (600 mg or 1200 mg) met the co-primary endpoints of clinical remission and endoscopic response at week 12 compared to placebo.

In the analysis plans for the US submission of the FORTIFY trial, a randomized-withdrawal maintenance trial of patients with clinical response to risankizumab-rzaa induction therapy, a significantly greater proportion of participants achieved the co-primary endpoints of endoscopic response and clinical remission with risankizumab-rzaa SC maintenance therapy at one year (52 weeks) for both assessed doses (360 mg or 180 mg), compared to those who were randomized to the withdrawal arm and received placebo SC (control group).

The safety profile of all tested doses of risankizumab-rzaa in moderate to severe Crohn's disease in the ADVANCE, MOTIVATE and FORTIFY studies was generally consistent with the known safety profile of risankizumab-rzaa.

SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea, abdominal pain, and rectal bleeding.It is a progressive disease, meaning it can get worse over time. Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically.

The ADVANCE and MOTIVATE studies are phase 3, multicenter, randomized, double-blind, placebo-controlled induction studies designed to evaluate the efficacy and safety of two doses of risankizumab-rzaa, 600 mg and 1200 mg, in adults with moderate to severe Crohn's disease, compared to placebo. The ADVANCE study included a mixed population of patients who had responded inadequately or are intolerant to conventional and/or biologic therapy. The MOTIVATE study evaluated patients who had responded inadequately or were intolerant to biologic therapy. Topline results of the studies were shared in January 2021, and additional analyses were presented at Digestive Disease Week (DDW) Virtual Conference 2021.

The FORTIFY study is a phase 3, multicenter, randomized, double-blind, control group, 52-week maintenance study designed to evaluate the efficacy and safety of risankizumab-rzaa 180 mg and 360 mg as maintenance therapy versus withdrawal who responded to risankizumab-rzaa induction treatment in the ADVANCE and MOTIVATE studies. Topline results were announced in June 2021. An open label extension of FORTIFY will continue to assess the long-term safety of risanzikumab-rzaa in subjects who completed participation in FORTIFY.

Skyrizi is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including Crohn's disease. In April 2019, Skyrizi received US Food and Drug Administration approval for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The approved dose for Skyrizi is 150 mg, administered by a prefilled pen or prefilled syringe at week 0 and 4, and every 12 weeks thereafter. Skyrizi was also approved by the European Commission in April 2019. Phase 3 trials of Skyrizi in psoriatic arthritis, Crohn's disease, and ulcerative colitis are ongoing. The use of risankizumab-rzaa in Crohn's disease is not approved and its safety and efficacy have not been established by regulatory authorities.

Skyrizi is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD.

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.