- Approval is based on results from three Phase 3 clinical
trials demonstrating RINVOQ achieved the co-primary endpoints
of clinical remission and endoscopic response as induction and
maintenance treatment 1,2,3,4,5
- Safety results were generally consistent with the known
safety profile of RINVOQ, with no new safety risks
observed 1-5,6,7,8,9
- RINVOQ is the first JAK inhibitor indicated in both Crohn's
disease and ulcerative colitis, and this approval underscores
AbbVie's longstanding commitment to deliver innovative medicines
for people living with immune-mediated gastrointestinal
diseases
- Milestone marks the seventh Health Canada-approved
indication for RINVOQ across gastroenterology, dermatology and
rheumatology 4
MONTREAL, Oct. 17,
2023 /CNW/ - AbbVie (NYSE: ABBV), today
announced that Health Canada has approved
RINVOQ® (upadacitinib, 45 mg [induction
dose] and 15 mg and 30 mg [maintenance dose]), an oral, once-daily
selective and reversible JAK inhibitor, for the treatment of adults
with moderately to severely active Crohn's disease.
![AbbVie Logo (CNW Group/AbbVie Canada) AbbVie Logo (CNW Group/AbbVie Canada)](https://mma.prnewswire.com/media/2249067/AbbVie_Canada_AbbVie_s_RINVOQ___upadacitinib__Receives_Health_Ca.jpg)
Crohn's disease is a chronic, systemic disease that manifests as
inflammation within the gastrointestinal (digestive) tract, causing
persistent diarrhea and abdominal pain.10,11 It is a
progressive disease, meaning it gets worse over time in a
substantial proportion of patients or may develop complications
that require urgent medical care, including surgery.12
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.11 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.13 More than 320,000 Canadians live
with IBD, and the rate of diagnosis is increasing amongst certain
demographics including seniors.12
"This approval is a significant milestone for the IBD community
as RINVOQ is the first JAK inhibitor indicated in both Crohn's
disease and ulcerative colitis. RINVOQ offers people living with
Crohn's disease a once-daily oral treatment capable of achieving
important endpoints like clinical remission and endoscopic
response, which can result in rapid and sustained symptom relief
that makes a meaningful difference in a person's daily life,"
explains Dr. Remo Panaccione, MD,
Professor of Medicine and Director of the IBD unit, University of Calgary. "In addition, this is the
first time we have seen steroid-free remission rates so early in a
clinical trial, which greatly raises the bar on our expectation of
patient outcomes in Crohn's disease."
"Crohn's disease robbed me of my quality of life. It became so
difficult to do the things I love to do, like travel, go out with
family and friends, or even just go to work. Everything I did was
influenced by my disease and I had no control. I wasn't able to
live my life the way I wanted to," explains Lyanne B., Edmonton, Alberta. "Finding a treatment that
works for me has made such a difference. Not only do I feel like
myself again, but I am able to find enjoyment in the little things
like taking my dogs for a walk or spending time with family. I am
so grateful for the chance to get my life back."
This approval is supported by data from three Phase 3 clinical
trials, including two induction studies (U-EXCEED & U-EXCEL)
and one maintenance study (U-ENDURE).1-5 Across all
three studies, significantly more patients treated with
upadacitinib achieved the co-primary endpoints of clinical
remission and endoscopic response, with clinical remission measured
by the Crohn's Disease Activity Index (CDAI) or by the
patient-reported symptoms of stool frequency/abdominal pain score
(SF/APS).1-5, The safety results of upadacitinib in
U-EXCEED, U-EXCEL and U-ENDURE were generally consistent with the
known safety profile of upadacitinib, with no new safety risks
observed.
Lori Radke, President and CEO,
Crohn's and Colitis Canada said, "Crohn's and Colitis Canada always
welcomes new treatments for people with Crohn's disease in
Canada. Crohn's and colitis are
chronic diseases that are debilitating, lead to hospitalizations
and surgeries, and have a tremendous impact on the quality of life
for the 322,000 Canadians living with them in Canada today. These diseases are complex and
often require a personalized approach and multiple treatment
options to achieve remission."
"For more than 20 years, AbbVie has worked hand-in-hand with the
IBD research community to advance patient-centered clinical
practice and elevate the standard of care, which ultimately makes a
significant difference in people's lives," said Tracey Ramsay, Vice President and General
Manager, AbbVie Canada. "We are proud of our incredible legacy in
gastroenterology, starting with HUMIRA14, and now with
SKYRIZI15 and RINVOQ. This new indication for RINVOQ in
Crohn's disease represents the third indication approved across our
IBD portfolio in the past year—a remarkable achievement that
demonstrates our longstanding commitment to delivering innovative
new therapies for Canadians living with IBD."
About the U-EXCEED and U-EXCEL
Induction and U-ENDURE Maintenance Studies
1,2,3,5
The three Phase 3 studies are multicenter, randomized,
double-blind, placebo-controlled studies to evaluate the efficacy
and safety of upadacitinib 45 mg once daily as induction
therapy, and upadacitinib 15 mg and 30 mg once daily as
maintenance therapy in adults with moderately to severely active
Crohn's disease. More information on these trials can be found on
www.clinicaltrials.gov (NCT03345836, NCT03345849,
NCT03345823).
About
RINVOQ® (upadacitinib)
4
Discovered and developed by AbbVie scientists, RINVOQ is a
once-daily oral medication in an extended-release tablet. It is a
selective Janus kinase (JAK) inhibitor that interferes with the
JAK-STAT signaling pathway, which is thought to play a role in
inflammatory response.
RINVOQ is indicated for the treatment of adults with moderately
to severely active rheumatoid arthritis who have had an inadequate
response or intolerance to methotrexate; for adults with active
psoriatic arthritis who have had an inadequate response or
intolerance to methotrexate or other DMARDs; for adults and
adolescents 12 years of age and older with refractory moderate to
severe atopic dermatitis who are not adequately controlled with a
systemic treatment or when use of those therapies is inadvisable;
for adults with active ankylosing spondylitis who have had an
inadequate response to a biologic DMARD or when use of those
therapies is inadvisable; for adults with active non-radiographic
axial spondyloarthritis (nr-axSpA) with objective signs of
inflammation who have had an inadequate response to a biologic
DMARD or when use of those therapies is inadvisable; and for adults
with moderately to severely active ulcerative colitis who have
demonstrated prior treatment failure, i.e., an inadequate response
to, loss of response to, or intolerance to at least one of
conventional, and/or biologic therapy.
For important safety information, please consult the RINVOQ
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
and solutions 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, and eye care – and products and
services in our Allergan Aesthetics portfolio. For more information
about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie
Canada on X (Twitter), on Instagram, or find us on
LinkedIn.
References
1 A Study of
the Efficacy and Safety of Upadacitinib (ABT-494) in Participants
With Moderately to Severely Active Crohn's Disease Who Have
Inadequately Responded to or Are Intolerant to Conventional and/or
Biologic Therapies. ClinicalTrials.gov. 2022. Available at:
https://clinicaltrials.gov/ct2/show/NCT03345849. Accessed
on June 3, 2022.
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2 A Study of
the Efficacy and Safety of Upadacitinib (ABT-494) in Participants
With Moderately to Severely Active Crohn's Disease Who Have
Inadequately Responded to or Are Intolerant to Biologic Therapy.
ClinicalTrials.gov. 2022. Available at:
https://clinicaltrials.gov/ct2/show/NCT03345836. Accessed
on June 3, 2022.
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3 A
Maintenance and Long-Term Extension Study of the Efficacy and
Safety of Upadacitinib (ABT-494) in Participants With Crohn's
Disease Who Completed the Studies M14-431 or M14-433.
ClinicalTrials.gov. 2022. Available at:
https://clinicaltrials.gov/ct2/show/NCT03345823. Accessed
on June 3, 2022.
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4 RINVOQ
(upadacitinib) product monograph. AbbVie Corporation. Available
at: https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/RINVOQ_PM_EN.pdf
Accessed October 17, 2023
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5 Loftus EV
Jr,et al. Upadacitinib Induction and Maintenance Therapy for
Crohn's Disease. N Engl J Med. 2023;388(21):1966-1980.
doi:10.1056/NEJMoa2212728
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6 Cohen S.,
et al. Safety profile of upadacitinib in rheumatoid arthritis:
integrated analysis from the SELECT phase III clinical programme.
Ann Rheum Dis. 2020 Oct 28;80(3):304-11.
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7 Mease,
P.J., et al. Upadacitinib in Patients with Psoriatic Arthritis and
Inadequate Response to Biologics: 56-Week Data from the Randomized
Controlled Phase 3 SELECT-PsA 2 Study. Rheumatol Ther. 2021 Apr 28.
doi: 10.1007/s40744-021-00305-z. Online ahead of print.
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8
Guttman-Yassky E., et al. Once-daily upadacitinib versus placebo in
adolescents and adults with moderate-to-severe atopic dermatitis
(Measure Up 1 and Measure Up 2): results from two replicate,
double-blind, randomized controlled phase 3 studies. Lancet.
doi:10.1016/s0140-6736(21)00588-2.
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9 Van der
Heijde, D., et al. Efficacy and safety of upadacitinib in patients
with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre,
randomised, double-blind, placebo-controlled, phase 2/3 trial.
Lancet. 2019 Dec 7;394(10214):2108-2117. doi:
10.1016/S0140-6736(19)32534-6. Epub 2019 Nov 12.
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and Colitis Canada. About Crohn's and Colitis. Available
at: https://crohnsandcolitis.ca/About-Crohn-s-Colitis/What-are-Crohns-and-Colitis.
Accessed September 20, 2023.
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11
Gastrointestinal Society. Crohn's Disease. Available
at: https://badgut.org/information-centre/a-z-digestive-topics/crohns-disease/.
Accessed September 20, 2023.
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12 The Facts
about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation
of America. 2014. Available at:
https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf.
Accessed on June 3, 2022.
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13 Crohn's
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Canada. Available
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Accessed on September 20, 2023.
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14 HUMIRA
(adalimumab) product monograph. AbbVie Corporation. Available
at: https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/HUMIRA_PM_EN.pdf.
Accessed on September 20, 2023.
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15 SKYRIZI
(rizankizumab) product monograph. AbbVie Corporation. Available
at: https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/SKYRIZI_PM_EN.pdf.
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SOURCE AbbVie Canada