Health Canada Approves AbbVie's RINVOQ for Giant Cell Arteritis Treatment

AbbVie's RINVOQ has been approved by Health Canada for treating giant cell arteritis in adults. The approval is based on the global Phase 3 SELECT-GCA clinical trial, which met its primary endpoint of sustained remission. This marks the eighth approved indication for RINVOQ in Canada, covering rheumatology, gastroenterology, and dermatology. RINVOQ is used in combination with corticosteroids or as monotherapy after corticosteroid discontinuation.

Health Canada has approved AbbVie's RINVOQ (upadacitinib) for the treatment of giant cell arteritis (GCA) in adults. The approval is based on the global Phase 3 SELECT-GCA clinical trial, which demonstrated sustained remission as its primary endpoint [1]. This marks the eighth approved indication for RINVOQ in Canada, covering various therapeutic areas such as rheumatology, gastroenterology, and dermatology.

GCA is a chronic autoimmune vasculitis that primarily affects adults over 50, with a significant prevalence among people of northern European descent, particularly women [2]. The condition causes inflammation of the temporal and other cranial arteries, the aorta, and its major branches, posing a risk of sudden, irreversible vision loss and stroke [3].

The SELECT-GCA trial involved 428 patients with GCA. The study found that 46.4% of patients receiving RINVOQ 15 mg with a 26-week corticosteroid taper achieved sustained remission from week 12 to 52, compared to 29.0% with placebo plus a 52-week steroid taper (p = 0.002) [4]. The safety profile of RINVOQ was generally consistent with that observed in other approved indications.

RINVOQ is used in combination with corticosteroids or as monotherapy following the discontinuation of corticosteroids. AbbVie's commitment to improving outcomes for Canadians living with autoimmune conditions is evident in this approval [5].

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