AbbVie’s Rinvoq cleared for giant cell arteritis in US

Title

AbbVie's Rinvoq (Upadacitinib) Secures FDA Approval as First Oral JAK Inhibitor for Giant Cell Arteritis

Keywords

• Rinvoq
• upadacitinib
• AbbVie
• FDA approval
• giant cell arteritis (GCA)
• JAK inhibitor
• SELECT-GCA trial
• vasculitis
• temporal arteritis
• steroid taper regimen

Key Facts

- FDA Approval:
The U.S. Food and Drug Administration has approved Rinvoq (upadacitinib) for the treatment of adults with giant cell arteritis (GCA), making it the first and only oral Janus kinase (JAK) inhibitor authorized for this indication in the U.S.1234.

- Clinical Evidence:
Approval was based on the phase 3 SELECT-GCA trial, where 46.4% of patients receiving Rinvoq (15mg daily) in combination with a 26-week steroid taper achieved sustained remission from week 12 to week 52, compared to 29% for those receiving placebo with a 52-week steroid taper (p=0.002)235.

- Reduced Disease Flare and Steroid Exposure:
Patients in the Rinvoq group experienced fewer disease flares (34.3% vs 55.6%) and lower cumulative steroid exposure compared to placebo, addressing a significant challenge in GCA management3.

- Ninth Indication:
This marks the ninth condition for which Rinvoq is approved in the U.S., spanning rheumatology, gastroenterology, and dermatology2.

- Disease Background:
GCA, also known as temporal arteritis, is the most common vasculitis in adults in Western countries, primarily affecting women over 50 and associated with headaches, jaw pain, visual disturbances, large artery complications, and cardiovascular risk3.

- Current Treatment Landscape:
Glucocorticoids (steroids) are the mainstay therapy for GCA but are linked to toxicities and high relapse rates, underscoring the need for alternative treatments like Rinvoq3.

- Mechanism of Action:
Upadacitinib is a JAK inhibitor that blocks intracellular signals responsible for inflammation, offering an oral, targeted therapeutic option5.

Sources:

1. https://news.abbvie.com/2025-04-29-RINVOQ-R-upadacitinib-Receives-U-S-FDA-Approval-for-Giant-Cell-Arteritis-GCA

2. https://www.prnewswire.com/news-releases/rinvoq-upadacitinib-receives-us-fda-approval-for-giant-cell-arteritis-gca-302441150.html

3. https://pmlive.com/pharma_news/abbvies-jak-inhibitor-rinvoq-granted-fda-approval-to-treat-giant-cell-arteritis/

4. https://www.pharmaceutical-technology.com/news/fda-abbvie-upadacitinib/

5. https://www.pharmacytimes.com/view/fda-approves-upadacitinib-for-adult-patients-with-giant-cell-arteritis