Health Canada Approves AbbVie's RINVOQ®  for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis

Health Canada Approves AbbVie's RINVOQ® for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis

- Approval is based on results from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which RINVOQ delivered rapid and meaningful disease control, meeting the primary endpoint of ASAS40 response at week 14 versus placebo 1
- RINVOQ is the first and only Janus Kinase (JAK) inhibitor approved to treat patients across the spectrum of axial spondyloarthritis (nr-axSpA and ankylosing spondylitis) in Canada 1, 2, 3

AbbVie (NYSE: ABBV), today announced that Health Canada has approved RINVOQ ® (upadacitinib, 15 mg), the first oral, once-daily selective and reversible JAK inhibitor for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response to a biologic disease modifying anti-rheumatic drug (DMARD) or when use of those therapies is inadvisable.

Logo de AbbVie (CNW Group/AbbVie Canada)

This indication follows the July 2022 Health Canada approval of RINVOQ for adults with active ankylosing spondylitis (AS) who have had an inadequate response to a biologic DMARD or when use of those therapies is inadvisable, making RINVOQ the first and only JAK inhibitor approved for the full spectrum of axial spondyloarthritis. 2

Nr-axSpA is a chronic, progressive inflammatory rheumatic disease that causes joint inflammation leading to back pain and stiffness. 4 It cannot be detected by x-ray, which makes it extremely difficult to diagnose. 5 Nr-axSpA and AS are considered as two sub-types of a broader condition called axial spondyloarthritis (axSpA). A recent multi-country study reported that approximately 16 percent of patients with nr-axSpA will progress to AS after five years. 6

"Non-radiographic axial SpA is a very complex disease that is difficult to diagnose. And yet early detection and treatment are critical to improving health outcomes," explained Dr. Denis Choquette , Rheumatologist at the Institut de Rhumatologie de Montréal and Scientific Director, Rhumadata. "This new indication for RINVOQ is a significant milestone for rheumatologists and patients. AxSpA is typically diagnosed in young people under 45 years old, so it is very encouraging to now have a new, oral therapeutic choice for patients."

"Today, as a patient, but also as Chair of the Canadian Spondyloarthritis Association, I can say that we are thrilled to learn that RINVOQ is now approved for the treatment of adults with non-radiographic axial spondyloarthritis. When I first started experiencing symptoms of nr-axSpA, I thought I had a back sprain from playing sports. That first flare went on for three months. Over time, I also experienced inflammatory flares in my ankles, neck, and shoulders. By age 33, I felt like an old man. Getting my diagnosis was difficult as I didn't have the typical AS inflammatory markers; my x-rays came back negative. Two years after the onset of pain, I was prescribed an MRI centered on the sacroiliac joints, which confirmed that I had nr-axSpA. My story is truly ironic because I was a doctor specializing in the musculoskeletal field, working with other experts, and we all missed my diagnosis for years. And yet comparatively, I was lucky; it takes, on average, seven to ten years for people to be diagnosed with this disease. As AS warriors, we can become resistant to medications with time and so access to new innovative medicines is crucial. My hope is that RINVOQ's approval is followed by timely and equitable access for all patients. This access is essential for people living with this painful and debilitating condition," said Dr. Élie Karam, Chair, Canadian Spondylitis Association.

This approval is supported by data from the Phase 3 SELECT-AXIS 2 clinical trial (Study 2), which evaluated the efficacy, safety, and tolerability of upadacitinib in patients with nr-axSpA. ii Study results show RINVOQ delivered rapid and meaningful disease control with nearly half of patients achieving the primary endpoint of ASAS40* versus placebo, as well as significant improvement in signs and symptoms of nr-axSpA at week 14. 1

*ASAS40 is a composite index that measures disease activity. 1 To achieve an ASAS40 response, a patient's disease activity must have improved by at least 40%, as well as improved by two units (on a 0 to 10 scale) in at least three of four disease areas assessed, and the remaining area must not have gotten worse, including back pain, patient global assessment of disease activity, physical function, and morning stiffness. 1

"For nearly a quarter century, AbbVie has been dedicated to discovering and delivering innovative therapies for people living with rheumatic diseases," added Tracey Ramsay , Vice President and General Manager, AbbVie Canada. "The needs and experiences of patients drive our relentless pursuit to improve the standards of care, which is why we are proud to now offer Canadians the first once-daily oral advanced therapy that works across the spectrum of axial spondyloarthritis."

About the SELECT-AXIS 2 trial program 7

SELECT-AXIS 2 was conducted as a master study protocol that contains two standalone studies with randomization, data collection, analysis and reporting conducted independently. The Phase 3, randomized, placebo-controlled, double-blind studies are evaluating the efficacy and safety of RINVOQ compared with placebo on reduction of signs and symptoms in adult participants with active axial spondyloarthritis (axSpA), including bDMARD-IR AS (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2). More information on this trial can be found at www.clinicaltrials.gov (NCT04169373).

About RINVOQ   ®   (upadacitinib) 2

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 (RA) who have had an inadequate response or intolerance to methotrexate, for adults with active psoriatic arthritis (PsA) 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 (AD) who are not adequately controlled with a systemic treatment or when use of those therapies is inadvisable, for adults with active ankylosing spondylitis (AS) who have had an inadequate response to a biologic DMARD or when use of those therapies is inadvisable, and 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.

For important safety information, please consult the RINVOQ Product Monograph at www.abbvie.ca .

About AbbVie in Rheumatology

For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Anchored by a longstanding commitment to discovering and delivering transformative therapies, we pursue cutting-edge science that improves our understanding of promising new pathways and targets, ultimately helping more people living with rheumatic diseases reach their treatment goals.

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, gynecology 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 @AbbViecanada on Twitter and Instagram , or find us on LinkedIn .

___________________________

1 Deodhar A, Van den Bosch F, Poddubnyy D, et al. U Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022;400:369–79. doi:10.1016/S0140-6736(22)01212-0.


2 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 May 8, 2023.


3 van der Heijde D, Baraliakos X, Sieper J, et al. Efficacy and safety of upadacitinib for active ankylosing spondylitis refractory to biological therapy: a double-blind, randomized, placebo-controlled phase 3 trial. Ann Rheum Dis. 2022;0:1–9. doi:10.1136/annrheumdis-2022-222608.


4 Sieper J, Poddubnyy D. Axial spondyloarthritis. Lancet 2017; 390: 73–84.


5 Deodhar AA, Understanding Axial Spondyloarthritis: A Primer for Managed Care. Am J Manag Care. 2019;25:S319-S330.


6 Poddubnyy D, et al. Radiographic Progression From Non-radiographic to Radiographic Axial Spondyloarthritis: Results From a 5-year Multicountry Prospective Observational Study. Ann Rheum Dis 2022;81:96-97


7 A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373 Accessed March 30, 2023

SOURCE AbbVie Canada

Cision View original content to download multimedia: https://www.newswire.ca/en/releases/archive/May2023/09/c5429.html

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  • BOTOX ® Cosmetic Will Provide 250 Entrepreneurs with Access to New Resources and Opportunities and Will Award 20 Grants Worth $20,000 Each to Support Business Goals.
  • By 2030, BOTOX ® Cosmetic Pledges to Empower 50,000 Entrepreneurs, Helping to Close the Confidence Gap.

- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced BOTOX ® Cosmetic's continued commitment to closing the Confidence Gap with the introduction of The Confidence Project: Empowering Women Entrepreneurs . The one & only BOTOX ® Cosmetic invites business owners to apply for this year's program starting today through May 9, 2025 at 11:59pm PT .

BOTOX® Cosmetic (onabotulinumtoxinA) Continues its Mission of Empowering Entrepreneurs Through

Women entrepreneurs continue to break barriers in the business world, with increasing efforts to close the Confidence Gap. When women founders are supported by mentors and have access to capital, they become agents of change. Seventy-one percent of businesswomen said their mentor was influential in their career advancement, with many using their income to uplift their families and community. 1

Since 2023, BOTOX ® Cosmetic has provided a total of $1 million dollars in grant funding across more than 40 founders, along with coaching and networking opportunities. This year, BOTOX ® Cosmetic is expanding to reach more founders by providing 250 entrepreneurs with access to The Confidence Project. Through a partnership with Hello Alice, an online platform that helps businesses launch and grow, each of the 250 entrepreneurs will participate in an intensive "Boostcamp" program, which will provide participants with skill-building, mentorship resources, and exclusive networking opportunities. After completing the course, they will leverage their newfound skills to pitch their business to a panel of aesthetic entrepreneurs, as well as key business leaders from Allergan Aesthetics and Hello Alice, for a chance to receive one of 20 $20,000 grants from BOTOX ® Cosmetic.

"BOTOX ® Cosmetic is committed to being a catalyst for confidence, whether that be by pursuing education, aesthetic treatment, or your entrepreneurial goals. Through The Confidence Project, we pledge to continue to uplift founders who've invested so much in their businesses," said Nicole Katz , Vice President, Customer Engagement and Corporate Affairs at Allergan Aesthetics. "We know when women have access to resources and capital, there's no limit to what they can achieve. We look forward to getting to know this year's cohort of founders and how they found the confidence to pursue their dreams."

"Our mission at Hello Alice is to help entrepreneurs access the funding, mentorship, and resources they need to succeed. BOTOX ® Cosmetic's The Confidence Project provides a powerful opportunity for women entrepreneurs to scale their businesses and create lasting change," said Elizabeth Gore , Co-Founder and President of Hello Alice. "Our partnership with BOTOX ® Cosmetic aims to foster long-term growth, confidence, and leadership for future generations of women in business, by investing in their success today."

Business owners and their cofounders interested in applying to The Confidence Project are encouraged to visit www.botoxcosmetic.com/realimpact . Applicants must agree to the official rules of the grant program and submissions must be received by May 9, 2025 , at 11:59pm PT . The 250 women entrepreneurs selected to participate in the Hello Alice Boostcamp will be announced in July, and the 20 grant recipients will be announced in October 2025 .

For more information on The Confidence Project, visit www.botoxcosmetic.com/realimpact and follow @botoxcosmetic on Instagram and YouTube .

About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com .

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.com . Follow @abbvie on LinkedIn   ,   Facebook , Instagram , X (formerly Twitter) , and YouTube .

Approved Uses
BOTOX ® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, frown lines between the eyebrows, and vertical bands connecting the jaw and neck (platysma bands) in adults.

IMPORTANT SAFETY INFORMATION

BOTOX ® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX ® Cosmetic:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, which can be severe and result in loss of life. You are at the highest risk if these problems are preexisting before injection. Swallowing problems may last for several months.
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms, including loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.

BOTOX ® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.

There has not been a confirmed serious case of spread of toxin effect when BOTOX ® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, forehead lines, and/or platysma bands.

BOTOX ® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving BOTOX ® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Do not receive BOTOX ® Cosmetic if you are allergic to any of the ingredients in BOTOX ® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc (rimabotulinumtoxinB), Dysport (abobotulinumtoxinA), Xeomin (incobotulinumtoxinA), Jeuveau (prabotulinumtoxinA-xvfs), Daxxify (daxibotulinumtoxinA-lanm), or Letybo (letibotulinumtoxinA-wlbg); or have a skin infection at the planned injection site. This list may not include all available botulinum toxin products.

Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects, including difficulty swallowing and difficulty breathing, from standard doses of BOTOX ® Cosmetic.

Tell your doctor about all your medical conditions, including surgery or plans to have surgery on your face, trouble raising your eyebrows, drooping eyelids, any other abnormal facial change, are pregnant or plan to become pregnant (it is not known if BOTOX ® Cosmetic can harm your unborn baby), or are breastfeeding or plan to (it is not known if BOTOX ® Cosmetic passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX ® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX ® Cosmetic in the past.

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc, Dysport, Xeomin, Jeuveau, Daxxify, or Letybo in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; or take aspirin-like products or blood thinners.

Other side effects of BOTOX ® Cosmetic include dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems, including double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of eyelids, and dry eyes.

For more information, refer to the Medication Guide or talk with your doctor.

To report a side effect, please call Allergan Aesthetics at 1-800-678-1605.

Please see BOTOX ® Cosmetic full Prescribing Information , including Boxed Warning and Medication Guide .

References:

  1. Barbara Kurshan. Forbes.com. Purpose-Driven Women: Unleash Your Potential Through Mentorship. 2023 https://www.forbes.com/sites/barbarakurshan/2023/06/13/purpose-driven-women-unleash-your-potential-through-mentorship/

© 2025 AbbVie. All rights reserved. BOTOX Cosmetic and its designs are trademarks of Allergan Holdings France SAS, an AbbVie company, or its affiliates.

Contacts:

Investors:
Liz Shea
Liz.Shea@AbbVie.com
(847) 935-2211

Media:
Ember Garrett
Ember.Garrett@allergan.com
(714) 246-3525

Business owners and their cofounders interested in applying to The Confidence Project are encouraged to visit www.botoxcosmetic.com/realimpact.

Allergan Aesthetics (PRNewsfoto/AbbVie)

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SOURCE AbbVie

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