RINVOQ® Receives Health Canada Notice of Compliance for Giant Cell Arteritis in adults

• RINVOQ is the first and only oral advanced therapy approved for the treatment of giant cell arteritis (GCA) in Canadian adults ¹
• GCA is the most common vasculitis in Canada , primarily affecting adults over 50 ²
• This marks the eighth approved indication for RINVOQ in Canada across rheumatology, gastroenterology and dermatology ³

AbbVie today announced that Health Canada has issued a Notice of Compliance for RINVOQ ® (upadacitinib) for the treatment of adults with giant cell arteritis (GCA), both used in combination with a tapering course of corticosteroids and as monotherapy following discontinuation of corticosteroids. 4

GCA is a chronic autoimmune vasculitis that causes inflammation of the temporal and other cranial arteries, the aorta and its major branches. It is estimated that thousands of Canadians over the age of 50, primarily over the age of 70 (80%), will develop GCA every year. ⁵ GCA is a medical emergency, requiring prompt diagnosis and treatment due to the risk of sudden, irreversible vision loss and stroke. ^{6 7} GCA is more prevalent among people of northern European descent, with women being significantly more affected than men. ⁸

"Steroids have been the mainstay of GCA therapy, but there is a high risk of toxicity, and many patients experience relapses," said Dr. Jean-Paul Makhzoum , MD, MSc, FRCPC, FACP. "This announcement offers the first oral approach that has demonstrated meaningful control of disease activity in clinical trials."

"We welcome Health Canada's approval of this important treatment option for Canadians living with giant cell arteritis", said Jon Stewart , President of Vasculitis Foundation Canada. "GCA typically impacts patients in their early retirement years with life-altering consequences. We look forward to a better future for GCA patients."

The Canadian authorization is supported by the global, pivotal Phase 3 SELECT-GCA clinical trial, which met its primary endpoint of sustained remission. ⁹ In the study, 46.4% of patients receiving RINVOQ 15 mg with a 26-week corticosteroid taper achieved sustained remission from week 12-52 versus 29.0% with placebo plus a 52-week steroid taper (p = 0.002).

During the 52-week, placebo-controlled period, the safety profile of RINVOQ was generally consistent with that observed in other approved indications.

''After getting diagnosed with GCA, the medication I was put on deregulated my blood pressure. I was always tired," shared René St-Laurent , from Rimouski , Québec. "My doctor spoke to me about a medication that was being studied in a clinical trial for this condition [which I later found out was RINVOQ]. I got my energy back, I'm very active [and] I don't have any more pain. I hope to benefit from it for a long time.''

"This Health Canada approval provides an important option that may allow Canadian patients living with GCA to achieve sustained remission," said Rami Fayed, General Manager, AbbVie Canada. "It underscores AbbVie's commitment to improving outcomes for millions of Canadians living with an autoimmune condition."

About SELECT-GCA
SELECT-GCA (M16-852) is a Phase 3, multicentre, randomized, double-blind placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib (RINVOQ) in 428 patients with GCA. The study consists of two periods. The first period, previously reported in April 2024 , evaluated the efficacy of upadacitinib in combination with a 26-week corticosteroid taper regimen compared to placebo in combination with a 52-week corticosteroid taper regimen. In addition, the study assessed the safety and tolerability of upadacitinib in these patients. The second period evaluated the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in the first period. For more information regarding this study, please visit ClinicalTrials.gov (Identifier NCT03725202).

About RINVOQ ^® (upadacitinib)
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 approved in Canada for the following indications:

• For adults with moderately to severely active rheumatoid arthritis (RA);
• For adults with active psoriatic arthritis (PsA);
• For adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis (AD);
• For adults with active ankylosing spondylitis (AS);
• For adults with active non-radiographic axial spondyloarthritis (nr-axSpA);
• For adults with moderately to severely active ulcerative colitis (UC);
• For adults with moderately to severely active Crohn's disease (CD); and
• For adults with giant cell arteritis (GCA).

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 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 Twitter, on Instagram or find us on LinkedIn.

SOURCE AbbVie Canada

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