AbbVie is set to expand the indication list for its immunology blockbuster, Rinvoq (upadacitinib).

The company has submitted applications to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to seek approval for the use of Rinvoq as a treatment for giant cell arteritis.

Rinvoq blocks the activity of Janus kinase (JAK) enzymes in the JAK-STAT signalling pathway, which plays a role in the release of pro-inflammatory cytokines. It has been approved by the FDA to treat seven autoimmune conditions, namely atopic dermatitis, ankylosing spondylitis, axial spondylarthritis, Crohn’s disease, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

Rinvoq is one of the top revenue-generating therapies for AbbVie, raking in approximately $4bn in sales last year, per the company’s financials. The therapy’s revenue is expected to soar over the next decade, with Rinvoq expected to pull in over $12bn in sales by 2030, as per GlobalData market analysis.

Rinvoq’s regulatory submissions are supported by the data from the placebo-controlled Phase III SELECT-GCA trial (NCT03725202). The study enrolled 438 participants who received either Rinvoq or placebo in combination with corticosteroids. The trial met its primary endpoint by inducing remission in 46% of the participants in the Rinvoq treatment group at 52 weeks, compared to a 29% remission rate in the placebo group.

Giant cell arteritis is an inflammatory condition that affects the blood vessels of the scalp, neck and arms. It is a common form of vasculitis and has an incidence rate of 18-29 cases per 100,000 people over 50 years of age.

AbbVie is also investigating Rinvoq in adults and adolescents with hidradenitis suppurativa, a chronic inflammatory condition. A placebo-controlled Phase III trial (NCT05889182) is evaluating Rinvoq in patients with moderate to severe hidradenitis suppurativa who have failed anti-TNF therapy.