AbbVie seeks to expand Rinvoq for giant cell arteritis

AbbVie has made significant moves by submitting regulatory applications for Rinvoq (upadacitinib) to the FDA and the European Medicines Agency for the treatment of adult patients with giant cell arteritis (GCA). This effort, announced on Friday, seeks to expand the indications for the oral JAK inhibitor, which is already approved for multiple immune-mediated inflammatory conditions.

The applications are backed by data from the Phase III SELECT-GCA study, which evaluated Rinvoq in combination with a 26-week steroid taper regimen in 428 patients with GCA. The promising results released in April showed that 46% of patients treated with Rinvoq reached the primary endpoint of sustained remission from weeks 12 through 52. In comparison, only 29% of patients in the placebo group, who followed a 52-week corticosteroid taper regimen, achieved the same outcome. The study also met key secondary endpoints, demonstrating a higher rate of sustained complete remission and a lower rate of disease flares in the Rinvoq group.

Roopal Thakkar, recently promoted to chief scientific officer at AbbVie, highlighted the limited treatment options currently available for GCA. Most patients with this condition are managed with glucocorticoids, and many struggle to discontinue them without experiencing a recurrence of symptoms. GCA can lead to severe symptoms such as headaches, jaw pain, and changes in vision, including sudden and permanent vision loss. Thakkar emphasized that if Rinvoq is approved for GCA, it could provide a new treatment option that reduces the need for glucocorticoids while maintaining control over the disease.

Rinvoq generated nearly $4 billion in sales last year, and along with IL-23 inhibitor Skyrizi (risankizumab), it is seen as a key growth driver in AbbVie's immunology portfolio. This is particularly important as biosimilar versions of AbbVie's blockbuster treatment Humira (adalimumab) begin to capture market share, albeit more slowly than anticipated.

Currently, Rinvoq is approved for a variety of conditions including rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and Crohn's disease. Beyond GCA, Rinvoq is undergoing Phase III trials for several other conditions, such as alopecia areata, hidradenitis suppurativa, Takayasu arteritis, lupus, and vitiligo.

The submission of these regulatory applications underscores AbbVie's commitment to expanding the use of Rinvoq to address unmet medical needs in patients with GCA. If granted approval, this could mark a significant advancement in the treatment landscape for this debilitating condition.