AbbVie's Upadacitinib: A Game Changer for Giant Cell Arteritis Patients

AbbVie (NYSE: ABBV) has received a positive CHMP opinion for its JAK inhibitor, upadacitinib (RINVOQ®), for the treatment of adult patients with giant cell arteritis (GCA). This is a significant milestone for AbbVie and a potential game-changer for GCA patients, as upadacitinib would become the first and only oral advanced therapy for this condition if approved by the European Commission in the first half of 2025.

GCA is an autoimmune disease that causes inflammation of the large and medium cranial arteries, resulting in potentially debilitating symptoms such as headache, jaw pain, and changes in or loss of vision. The current treatment landscape relies heavily on high-dose corticosteroids, often for extended periods, with tocilizumab as the only approved targeted therapy. However, these treatments come with significant side effects, particularly in the elderly population typically affected by GCA.

Upadacitinib, a once-daily oral medication, offers a promising alternative with its ability to reduce corticosteroid exposure and maintain long-term disease control. The positive CHMP opinion is based on results from the pivotal Phase 3 SELECT-GCA trial, which demonstrated that 46% of patients treated with upadacitinib (15 mg) in combination with a 26-week steroid taper regimen achieved sustained remission from week 12 through week 52, compared to 29% of patients receiving placebo with a 52-week steroid taper regimen.



The safety profile of upadacitinib in GCA was generally consistent with that observed in other approved indications, with no new safety signals identified. This consistency in safety profile across different indications is crucial for market acceptance and patient adherence, as it allows physicians to prescribe upadacitinib with confidence and patients to adhere to their treatment regimen.

If approved, upadacitinib would represent the eighth indication for RINVOQ in Europe, further cementing the drug's role as a cornerstone of AbbVie's post-Humira growth strategy. The approval of upadacitinib for GCA would also align with AbbVie's investment philosophy focused on stability and consistent growth, as it expands the use of upadacitinib across multiple immunological conditions where JAK inhibition has demonstrated efficacy.

In conclusion, the positive CHMP opinion for upadacitinib in GCA is a significant step towards improving outcomes for patients suffering from this potentially devastating condition. With its ability to reduce corticosteroid exposure and maintain long-term disease control, upadacitinib offers a promising alternative to current treatment options. If approved, upadacitinib would not only address a significant unmet need in the GCA market but also contribute to AbbVie's long-term financial success by expanding its immunology franchise and offsetting revenue pressure from biosimilar competition to Humira.