Abbvie: notice of compliance for Rinvoq in giant cell arteritis

Abbvie: notice of compliance for Rinvoq in giant cell arteritis

Health Canada has issued a Notice of Compliance for AbbVie's Rinvoq (upadacitinib) for the treatment of giant cell arteritis (GCA) in Canadian adults. This marks the eighth approved indication for Rinvoq in Canada, expanding its use across various therapeutic areas including rheumatology, gastroenterology, and dermatology [1].

Giant cell arteritis (GCA) is a chronic autoimmune vasculitis that primarily affects adults over 50, with a significant prevalence among people of northern European descent and women. It is estimated that thousands of Canadians over the age of 50, primarily over 70, develop GCA each year. GCA is a medical emergency, requiring prompt diagnosis and treatment due to the risk of sudden, irreversible vision loss and stroke [2].

Rinvoq is a once-daily oral medication in an extended-release tablet, acting as a Janus kinase (JAK) inhibitor that interferes with the JAK-STAT signaling pathway involved in inflammatory response. The Canadian authorization is supported by the global, pivotal Phase 3 SELECT-GCA clinical trial, which met its primary endpoint of sustained remission [1].

In the SELECT-GCA 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). The safety profile of Rinvoq during the 52-week, placebo-controlled period was generally consistent with that observed in other approved indications [1].

This approval provides an important treatment option for Canadians living with GCA, potentially allowing patients to achieve sustained remission. AbbVie's commitment to improving outcomes for millions of Canadians living with autoimmune conditions is underscored by this latest approval [1].

References:
[1] https://www.newswire.ca/news-releases/rinvoq-r-upadacitinib-receives-health-canada-notice-of-compliance-noc-for-giant-cell-arteritis-in-adults-837757564.html
[2] https://www.albertahealthservices.ca/assets/info/aph/if-aph-provincial-giant-cell-arteritis-primary-care-clinical-pathway.pdf