Health Canada Approves RINVOQ for Giant Cell Arteritis in Adults

Health Canada has approved AbbVie's RINVOQ (upadacitinib) for the treatment of giant cell arteritis (GCA) in Canadian adults. RINVOQ is the first oral advanced therapy approved for GCA and marks the eighth approved indication for RINVOQ in Canada. GCA is a chronic autoimmune vasculitis that affects thousands of Canadians over 50, primarily over 70, and can cause inflammation of the temporal and cranial arteries, aorta, and its major branches. The approval is based on the global, pivotal Phase 3 SELECT-GCA clinical trial.

Health Canada has approved AbbVie's RINVOQ (upadacitinib) for the treatment of giant cell arteritis (GCA) in Canadian adults. This approval marks the eighth indication for RINVOQ in Canada, following its successful clinical trials and regulatory reviews. GCA is a chronic autoimmune vasculitis that primarily affects adults over 50, with a significant prevalence among those over 70. The condition can lead to inflammation of the temporal and cranial arteries, aorta, and its major branches, potentially causing sudden, irreversible vision loss and stroke.

The approval is based on the global, pivotal Phase 3 SELECT-GCA clinical trial, which demonstrated the efficacy and safety of RINVOQ in combination with a tapering course of corticosteroids and as monotherapy following discontinuation of corticosteroids. In the trial, 46.4% of patients receiving RINVOQ 15 mg with a 26-week corticosteroid taper achieved sustained remission from week 12-52, compared to 29.0% with placebo plus a 52-week steroid taper (p = 0.002). The safety profile of RINVOQ was generally consistent with that observed in other approved indications.

The approval of RINVOQ for GCA offers an important treatment option for Canadians living with the condition. Dr. Jean-Paul Makhzoum, MD, MSc, FRCPC, FACP, noted the significance of this approval, stating, "Steroids have been the mainstay of GCA therapy, but there is a high risk of toxicity, and many patients experience relapses. This announcement offers the first oral approach that has demonstrated meaningful control of disease activity in clinical trials." The Canadian authorization is supported by the global, pivotal Phase 3 SELECT-GCA clinical trial, which met its primary endpoint of sustained remission.

About RINVOQ:
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 various indications, including moderately to severely active rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, and Crohn's disease, in addition to GCA.

References:
[1] https://finance.yahoo.com/news/rinvoq-upadacitinib-receives-health-canada-120000655.html