AbbVie Submits Regulatory Application to FDA for Risankizumab-rzaa (SKYRIZI®) for the Treatment of Patients 16 Years and Older with Moderate to Severe regional enteritis
today announced that it’s submitted an application to the U.S. 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 regional enteritis . The submission is supported by safety and efficacy data from three Phase 3 studies – ADVANCE, MOTIVATE and FORTIFY.
“While there are advancements in care, many of us with regional enteritis don’t achieve lasting remission,” said Tom Hudson, senior vice chairman of research and development, chief scientific officer, AbbVie. “This submission is a crucial breakthrough in our commitment to providing a further treatment option for those that struggle with this debilitating and sometimes unpredictable disease.”
In the analysis plans for the U.S. submission of the ADVANCE and MOTIVATE induction studies, a significantly greater proportion of patients with regional enteritis 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.1,2
In the analysis plans for the U.S. 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 that were randomized to the withdrawal arm and received placebo SC (control group).3
The safety profile of all tested doses of risankizumab-rzaa in moderate to severe regional enteritis within the ADVANCE, MOTIVATE and FORTIFY studies was generally according to the known safety profile of risankizumab-rzaa.1-7
SKYRIZI is a component of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
About regional enteritis
Crohn’s disease may be a chronic, systemic disease that manifests as inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea, abdominal pain, and rectal bleeding.9-11 it’s a progressive disease, meaning it can worsen over time.10,11 Because the signs and symptoms of regional enteritis are unpredictable, it causes a big burden on people living with the disease—not only physically, but also emotionally and economically.8
About the ADVANCE and MOTIVATE Studies12-14
The ADVANCE and MOTIVATE studies are Phase 3, multicenter, randomized, double-blind, placebo-controlled induction studies designed to guage the efficacy and safety of two doses of risankizumab-rzaa, 600 mg and 1200 mg, in adults with moderate to severe regional enteritis , compared to placebo. The ADVANCE study included a mixed population of patients who had responded inadequately or are intolerant to standard 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 extra analyses were presented at Digestive Disease Week® (DDW) Virtual Conference 2021. More information are often found on www.clinicaltrials.gov (ADVANCE: NCT03105128; MOTIVATE: NCT03104413).
About the FORTIFY Study3,15
The FORTIFY study may be a Phase 3, multicenter, randomized, double-blind, control group, 52-week maintenance study designed to guage the efficacy and safety of risankizumab-rzaa 180 mg and 360 mg as maintenance therapy versus withdrawal who skilled risankizumab-rzaa induction treatment within the ADVANCE and MOTIVATE studies. Topline results were announced in June 2021. An open label extension of FORTIFY will still assess the long-term safety of risanzikumab-rzaa in subjects who completed participation in FORTIFY. More information are often found on www.clinicaltrials.gov (NCT03105102).
About Risankizumab-rzaa (SKYRIZI®)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.16 IL-23, a cytokine involved in inflammatory processes, is assumed to be linked to variety of chronic immune-mediated diseases, including regional enteritis .16,17 In April 2019, SKYRIZI received U.S. 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 each 12 weeks thereafter. SKYRIZI was also approved by the ecu Commission in April 2019. Phase 3 trials of SKYRIZI in rheumatoid arthritis , regional enteritis , and colitis are ongoing.13-15, 18-21 the utilization of risankizumab-rzaa in regional enteritis isn’t approved and its safety and efficacy haven’t been established by regulatory authorities.
About Risankizumab-rzaa (SKYRIZI®) within the United States16
SKYRIZI may be a prescription drug wont to treat adults with moderate to severe plaque psoriasis who may enjoy taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
Important Safety Information
What is the foremost important information I should realize SKYRIZI® (risankizumab-rzaa)?
SKYRIZI may cause serious side effects, including infections. SKYRIZI may be a prescription drug which will lower the power of your system to fight infections and should increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and should treat you for TB before you start treatment with SKYRIZI if you’ve got a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.
Tell your healthcare provider directly if you’ve got an infection or have symptoms of an infection, including:
fever, sweats, or chills
warm, red, or painful skin or sores on your body different from your psoriasis
diarrhea or stomach pain
shortness of breath
blood in your mucus (phlegm)
burning once you urinate or urinating more often than normal
Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you: