AbbVie Seeks FDA and EMA Approval for Upadacitinib in Giant Cell Arteritis

AbbVie has announced the submission of applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for a new indication of upadacitinib (RINVOQ®; 15 mg, once daily) for treating adult patients with giant cell arteritis (GCA). GCA is an autoimmune disease affecting medium and large arteries, leading to symptoms such as headaches, jaw pain, and vision changes, including sudden and permanent vision loss.

Presently, there are limited approved treatment options for GCA, with most patients relying on glucocorticoids. Unfortunately, many patients struggle to discontinue glucocorticoids without experiencing a recurrence of GCA symptoms. Roopal Thakkar, M.D., AbbVie's executive vice president of research and development, emphasized the importance of maintaining remission and reducing glucocorticoid use in GCA management.

The regulatory submissions are backed by results from the SELECT-GCA Phase 3 study. This study assessed the safety and efficacy of upadacitinib in patients with GCA.

The SELECT-GCA study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving 428 patients with GCA. The study has two periods. The first period evaluated the efficacy of upadacitinib combined with a 26-week corticosteroid taper regimen against a placebo with a 52-week corticosteroid taper regimen. It also examined the safety and tolerability of upadacitinib. The ongoing second period aims to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission during the first period.

Giant cell arteritis, also known as temporal arteritis, involves granulomatous inflammation of the three-layered vessel wall, affecting temporal and other cranial arteries, as well as the aorta and other large arteries. The condition predominantly affects Caucasian women over the age of 50, particularly those between 70 and 80 years old. While women are more prone to GCA, men are more likely to exhibit ocular manifestations of the disease.

Upadacitinib (RINVOQ®), discovered and developed by AbbVie scientists, is a JAK inhibitor under investigation for several immune-mediated inflammatory diseases. In enzymatic and cellular assays, RINVOQ showed greater inhibitory potency for JAK-1 compared to JAK-2, JAK-3, and TYK-2. However, the relevance of inhibiting specific JAK enzymes to therapeutic effectiveness and safety is not yet known. Upadacitinib is undergoing Phase 3 clinical trials for various conditions, including alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.

At present, the use of upadacitinib in giant cell arteritis has not been approved, and its safety and efficacy have not been evaluated by regulatory authorities.

AbbVie remains committed to improving care for individuals with rheumatic diseases, leveraging over 20 years of experience in this field. The company's dedication to discovering transformative therapies aims to help more people with rheumatic conditions achieve their treatment goals.

AbbVie's mission centers on discovering and delivering innovative medicines and solutions to address serious health issues and future medical challenges. The company strives to make a significant impact on people's lives across key therapeutic areas, including immunology, oncology, neuroscience, and eye care, alongside products and services in its Allergan Aesthetics portfolio.