- Approval is based on results from three Phase 3 studies: two
for induction and one for maintenance 1,2,3
- In clinical trials, patients taking RINVOQ achieved the
primary endpoint of clinical remission (per modified Mayo Score [mMS]) at weeks 8 and 52
1,2,3
- Safety results in ulcerative colitis were generally
consistent with the known safety profile of RINVOQ, with no new
important safety risks observed 4,5,6,7,8,9
- Approval underscores AbbVie's longstanding commitment to
deliver innovative medicines for people living with immune-mediated
gastrointestinal diseases
- Milestone marks the sixth Health Canada-approved indication
for RINVOQ across gastroenterology, dermatology and rheumatology
10
MONTREAL, July 25,
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 ulcerative colitis (UC) 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.
Ulcerative colitis is a chronic, immune-mediated inflammatory
bowel disease (IBD) of the large intestine that can lead to
substantial burden and often disability among
patients.11,12 Canada
has one of the highest rates of inflammatory bowel disease in the
world, the two main forms of which are Crohn's disease and
ulcerative colitis.13 More than 300,000 Canadians are
living with IBD, and the rate of diagnosis is increasing amongst
certain demographics including seniors.13
"Patients with ulcerative colitis live with unpredictable
symptoms, including bowel urgency, uncontrollable diarrhea,
abdominal pain and rectal bleeding, which can significantly affect
their quality of life often paralyzing them during a flare. The
impacts of UC are far-reaching, affecting patients beyond physical
symptoms with significant impacts on mental health." explains Dr.
Remo Panaccione, MD, Professor of
Medicine and Director of the IBD unit, University of Calgary. "The approval of RINVOQ is
exciting and welcome news, as it represents a new selective class
of treatment and is a once-daily oral therapy approved in UC.
RINVOQ has demonstrated it can rapidly improve symptoms within days
to get patients back on track with their lives while also healing
the damaged bowel, paving the road to a brighter future without
flares."
"At the height of my symptoms, UC dictated my life. For about
five years I struggled with pain and worry. Going out to work or
anything else was near impossible. Always worrying about needing a
nearby restroom or what to be careful of eating had been recurring
thoughts that tormented me daily. When you do everything you can to
feel better but see no real results, you feel ready to give up,"
explained Ryan L., of Brampton,
Ontario. "Once I found a treatment that worked for me, I
felt normal again, which seemed like a miracle. Being able to go
out again without the added worry makes one appreciate what it
means to be healthy. I'm glad this new medication will be available
for Canadians living with UC."
This approval is supported by data from two induction studies,
U-ACHIEVE induction and U-ACCOMPLISH, and one maintenance study,
U-ACHIEVE maintenance.1,2,3 Across all three Phase 3
studies, significantly more patients treated with RINVOQ
achieved the primary endpoint of clinical remission (per
modified Mayo Score [mMS] at weeks 8
and 52.1,2,3 In addition, each study met all
prespecified secondary endpoints, including symptoms, endoscopy and
histology.4 Additionally, safety results of
RINVOQ in UC were consistent with the known safety profile of
RINVOQ in rheumatoid arthritis, with no new important safety risks
observed.4-9
"In a recent patient survey, we asked people if the currently
available medications were adequate to control their disease.
Sadly, only 24% of those living with IBD thought that the available
medications were adequate," says Gail
Attara, President and Chief Executive Officer of the
Gastrointestinal Society. "People living with ulcerative colitis
need access to new treatment options to help manage the unrelenting
bowel symptoms and to hope for mucosal healing. I am pleased to
learn that Health Canada has now approved RINVOQ for the treatment
of adults with moderately to severely active ulcerative
colitis."
"With more than 30 ongoing or planned trials in IBD, we are
relentless in our commitment to elevate the standard of care for
patients. Our many years of research experience have given us
invaluable insights into the challenges faced by people living with
UC, and a deep understanding of the continued need for new
treatment options," said Tracey
Ramsay, Vice President and General Manager, AbbVie Canada.
"We celebrate this approval as it will make a meaningful difference
in the lives of Canadians with UC."
About the U-ACHIEVE and
U-ACCOMPLISH Induction, and U-ACHIEVE Maintenance
Studies1,2,3
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 subjects with moderately to severely active
ulcerative colitis. Topline results of the U-ACHIEVE induction
study were announced in December
2020, topline results of the second induction study,
U-ACCOMPLISH, were announced in February 2021, and topline results of the
U-ACHIEVE maintenance study were announced in June 2021. More information can be found on
http://www.clinicaltrials.gov (NCT03006068, NCT03653026,
NCT02819635).
About
RINVOQ®
(upadacitinib)10
Discovered and developed by AbbVie scientists, RINVOQ is a
once-daily oral medication in an extended-release tablet. It is a
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
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
|
__________________________
|
1 Vermeire, S., et al. OP23 Efficacy
and safety of upadacitinib as induction therapy in patients with
Moderately to Severely Active Ulcerative Colitis: Results from
phase 3 U-ACCOMPLISH study, Journal of Crohn's and Colitis, Volume
15, Issue Supplement 1. May 2021.
2 Danese, S., et al. OP24 Efficacy and safety of
upadacitinib induction therapy in patients with Moderately to
Severely Active Ulcerative Colitis: Results from the phase 3
U-ACHIEVE study, Journal of Crohn's and Colitis, Volume 15, Issue
Supplement 1. May 2021.
3 Danese, S., et al. OP08 The effects of maintenance
therapy with upadacitinib on abdominal pain, bowel urgency, and
fatigue in patients with moderately to severely active Ulcerative
Colitis: Phase 3 U-ACHIEVE maintenance results, Journal of Crohn's
and Colitis, Volume 16, Issue Supplement 1. January 2022.
4 Danese S, Vermeire S, Zhou W, et al. Upadacitinib
as induction and maintenance therapy for moderately to severely
active ulcerative colitis: results from three phase 3, multicentre,
double-blind, randomised trials. The Lancet.
2022;399(10341):2113- 2128. doi:10.1016/S0140-6736(22)00581-5
5 Mease PJ, Lertratanakul A, Anderson JK, et al.
Upadacitinib for psoriatic arthritis refractory to biologics:
SELECT-PsA 2. Annals of the Rheumatic Diseases. 2021;80(3):312-320.
doi:10.1136/annrheumdis-2020-218870
6 Guttman-Yassky E, Teixeira HD, Simpson EL, 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, randomised
controlled phase 3 trials. The Lancet.
2021;397(10290):2151-2168. doi:10.1016/S0140-6736(21)00588-2
7 van der Heijde D, Song IH, Pangan AL, 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;394(10214):2108- 2117. doi:10.1016/S0140-6736(19)32534-6
8 A Study to Evaluate the Long-Term Safety and Efficacy
of Upadacitinib (ABT-494) in Participants with Ulcerative Colitis
(UC). Clinicaltrials.gov; 2022. Accessed September 27,
2022. https://clinicaltrials.gov/ct2/show/NCT03006068
9 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.
10 RINVOQ (upadacitinib) product monograph. AbbVie
Corporation. Available at:
https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/RINVOQ_PM.pdf.
Accessed July 25, 2023.
11 Gajendran M., et al. A comprehensive review and
update on ulcerative colitis. Dis Mon. 2019 Dec;65(12):100851. doi:
10.1016/j.disamonth.2019.02.004. Epub 2019 Mar 2.
12 Mehta F. Report: economic implications of
inflammatory bowel disease and its management. Am J Manag Care.
2016 Mar;22(3 Suppl):s51-60.
13 Crohn's and Colitis Canada 2023 Impact of
Inflammatory Bowel Disease in Canada. Available at:
https://crohnsandcolitis.ca/Crohns_and_Colitis/documents/reports/2023-IBD-Report-English-LR.pdf?ext=.pdf.
Accessed July 12, 2023.
|
SOURCE AbbVie Canada