- Third approved indication for SKYRIZI (rizankizumab) is
supported by safety and efficacy data from two induction and one
maintenance Phase 3 clinical trials: ADVANCE, MOTIVATE and
FORTIFY
1,2,3,
- As early as Week 4 in the induction studies, clinical
response and clinical remission were achieved by significantly more
people treated with SKYRIZI versus placebo
1,2,3
- Approval represents AbbVie's longstanding dedication to
delivering innovative medicines for people living with
immune-mediated gastroenterological diseases
MONTREAL, Oct. 20,
2022 /CNW/ - AbbVie (NYSE: ABBV) today announced
Health Canada approval for SKYRIZI® (risankizumab
600 mg intravenous [IV] induction at Week 0, Week 4 and Week 8,
followed by 360 mg subcutaneous [SC] injection maintenance at Week
12 and every eight weeks thereafter) for the treatment of adults
with moderately to severely active Crohn's disease who have had an
inadequate response, intolerance, or demonstrated dependence to
corticosteroids; or an inadequate response, intolerance, or
loss of response to immunomodulators or biologic therapies.
Crohn's disease is a chronic, systemic disease that manifests as
inflammation within the gastrointestinal (or digestive) tract,
causing persistent diarrhea and abdominal
pain.4 It is a progressive disease, meaning
it gets worse over time, and in many cases leads to
surgery.4 Canada has one of the highest
rates of inflammatory bowel disease (IBD) in the world, the two
main forms of which are Crohn's disease and ulcerative
colitis.5 More than 300,000 Canadians live with IBD, and
the rate of diagnosis is increasing amongst certain demographics
including seniors.5,6
"The clinical trials for SKYRIZI in Crohn's disease have helped
raise the bar in IBD research through more stringent endpoints and
innovative clinical trial design. Beyond the traditional endpoint
of clinical remission, this is the first time we have seen a
co-primary endpoint of endoscopic response in a Phase 3 trial,
which is very exciting," says Dr. Remo
Panaccione, MD, Professor of Medicine and Director of the
IBD unit, University of Calgary. "In
addition to helping patients get better quickly, there was evidence
of significant healing of the bowel within three months. It has
been shown that when people achieve endoscopic healing, they have
lower rates of hospitalizations and surgeries, and an overall
improved quality of life. SKYRIZI has also been used successfully
in other therapeutic areas and comes with a well-established safety
profile that will be also welcomed by patients.
"Living with Crohn's disease means having a hidden disease that
wreaks havoc on your mental health. I cannot be a mom or a wife
when I am having a flare up. Because Crohn's disease is
unpredictable, I was often on edge, waiting for that feeling of
urgency to strike and hoping a bathroom would be available,"
explains Lindsey Rion of
Spruce Grove, Alberta. "Finding a
treatment that works for me has been life-altering. I am physically
healing and my mental health has also improved. I'm so pleased
that Canadians living with Crohn's disease will now have a new
medication available to them, as having multiple approved treatment
options is critical."
This approval is supported by data from three Phase 3 clinical
trials ̶ ADVANCE, MOTIVATE (induction studies) and
FORTIFY (maintenance study).1,2,3 Across all three
studies, significantly more patients treated with risankizumab
achieved the co-primary endpoints of endoscopic response and
clinical remission.1,2,3,7,8 This includes
statistically significant improvements with 600 mg intravenous
infusions for the ADVANCE and MOTIVATE induction studies on these
primary endpoints at Week 12 compared to placebo.1,2,7
Additionally, a significantly greater proportion of patients
treated with risankizumab 360 mg subcutaneous injections achieved
endoscopic response and clinical remission at 52 weeks compared to
placebo withdrawal (patients treated with placebo after
risankizumab induction) in the FORTIFY maintenance
study.3,8 Safety results of risankizumab in Crohn's
disease were consistent with the known safety profile of
risankizumab, with no new safety risks
observed.1,2,3,7,8,9,10
"We are excited that a new treatment has been approved for use
in people with Crohn's disease in Canada. Crohn's disease and ulcerative colitis
are debilitating diseases, often leading to multiple
hospitalizations and surgeries, and they have a tremendous impact
on quality of life. These diseases are complex and often require a
personalized approach and multiple treatment options to bring about
remission. It's important that Canadians have access to new
treatment options because not all therapies will work for
everyone, and many people have run out of options. Crohn's and
Colitis Canada continues to advocate for improved coverage and
timely access to new treatments on public and private drug plans,"
says Lori Radke, President and CEO
of Crohn's and Colitis Canada.
"For more than 15 years, we have worked side-by-side with the
Canadian IBD research community to advance the standards of care in
Crohn's disease. We are proud of our commitment to investigating
treatment approaches that go beyond managing symptoms to focus on
changing the course of disease management," adds Tracey Ramsay, Vice President and General
Manager, AbbVie Canada. "This approval represents the first new
treatment option in six years for people with moderately to
severely active Crohn's disease, and we are pleased that Canadians
will now be able to benefit from this therapy."
SKYRIZI (risankizumab) is part of a collaboration between
Boehringer Ingelheim and AbbVie, with AbbVie leading development
and commercialization globally.
About the ADVANCE and MOTIVATE Inductions Studies, and the
FORTIFY Maintenance Study1,2,3
The three Phase 3 studies are multicenter, randomized,
double-blind, placebo-controlled studies to demonstrate the
efficacy and safety of risankizumab 600 mg as induction therapy,
and risankizumab 360 mg as maintenance therapy in subjects with
moderately to severely active Crohn's disease. More information can
be found on www.clinicaltrials.gov (ADVANCE: NCT03105128; MOTIVATE:
NCT03104413, FORTIFY: NCT03105102).
About SKYRIZI®
(risankizumab)11
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. SKYRIZI is also approved in Canada for the treatment of moderate to severe
plaque psoriasis in adult patients who are candidates for systemic
therapy or phototherapy, and for the treatment of adult patients
with active psoriatic arthritis.
For important safety information, please consult the SKYRIZI
Product Monograph at www.abbvie.ca.
About AbbVie in
Gastroenterology
AbbVie has focused on improving care in gastroenterology for
more than 10 years. With a robust clinical trial program in
inflammatory bowel disease (IBD), we are committed to cutting-edge
research to drive new discoveries and developments in Crohn's
disease and ulcerative colitis. By innovating, learning and
adapting, AbbVie aspires to eliminate the burden of IBD and make a
positive long-term impact in the lives of people with IBD.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across our
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.ca. Follow AbbVie Canada on Twitter,
on Instagram, or find us on LinkedIn.
References
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1 A Study of
the Efficacy and Safety of Risankizumab in Participants With
Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov
2022. Available
at https://www.clinicaltrials.gov/ct2/show/NCT03105128.
Accessed on September 28, 2022.
|
|
2 A Study of
the Efficacy and Safety of Risankizumab in Participants With
Moderately to Severely Active Crohn's Disease Who Failed Prior
Biologic Treatment. ClinicalTrials.gov 2022. Available
at https://clinicaltrials.gov/ct2/show/NCT03104413. Accessed
on September 28, 2022.
|
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3 A Study of
the Efficacy and Safety of Risankizumab in Participants With
Crohn's Disease. ClinicalTrials.gov 2022. Available
at https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed
on September 28, 2022.
|
|
4 Kaplan G.
The global burden of IBD: from 2015 to 2025. Nat Rev
Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi:
10.1038/nrgastro.2015.150.
|
|
5 Crohn's
and Colitis Canada 2018 Impact of Inflammatory Bowel Disease in
Canada. Available at:
https://crohnsandcolitis.ca/Crohns_and_Colitis/documents/reports/2018-Impact-Report-LR.pdf.
Accessed September 28, 2022.
|
|
6 Crohn's
and Colitis Canada 2021 Impact of COVID-19 & Inflammatory Bowel
Disease in Canada. Available at:
https://crohnsandcolitis.ca/Crohns_and_Colitis/documents/reports/COVID-19/2021-COVID19-IBD-Report_V9.pdf.
Accessed September 28, 2022.
|
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7 D'Haens
G., et al. Risankizumab as Induction Therapy for Crohn's Disease.
Lancet.
|
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8 Ferrante
M., et al. Risankizumab as Maintenance Therapy for Crohn's Disease.
Lancet.
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9 A Study
Comparing Risankizumab to Placebo in Participants With Active
Psoriatic Arthritis Including Those Who Have a History of
Inadequate Response or Intolerance to Biologic Therapy(ies)
(KEEPsAKE2). ClinicalTrials.gov. 2022. Available
at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed
on September 28, 2022.
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10 BI 655066
(Risankizumab) Compared to Placebo and Active Comparator
(Ustekinumab) in Patients With Moderate to Severe Chronic Plaque
Psoriasis. ClinicalTrials.gov. 2021. Available
at: https://clinicaltrials.gov/ct2/show/NCT02684370. Accessed
on September 28, 202s.
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11 SKYRIZI
(risankizumab) product monograph. AbbVie Corporation. Available at:
https://www.abbvie.ca/content/dam/abbviedotcom/ca/en/documents/products/SKYRIZI_PM_EN.pdf
Accessed October 20, 2022.
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SOURCE AbbVie Canada