AbbVie seeks ninth indication for Rinvoq

AbbVie is poised to broaden the therapeutic applications of its immunology blockbuster, Rinvoq (upadacitinib). The pharmaceutical giant has recently submitted regulatory applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to gain approval for Rinvoq as a treatment for giant cell arteritis.

Rinvoq functions by inhibiting the activity of Janus kinase (JAK) enzymes in the JAK-STAT signaling pathway. This pathway is crucial in the release of pro-inflammatory cytokines. Currently, Rinvoq has received FDA approval to treat eight different autoimmune conditions: atopic dermatitis, ankylosing spondylitis, axial spondylarthritis, Crohn’s disease, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, and polyarticular juvenile idiopathic arthritis.

Financially, Rinvoq is one of AbbVie's top-performing therapies. The drug generated approximately $4 billion in sales last year, according to the company's financial reports. Analysts expect Rinvoq’s revenue to surge in the coming decade, with projections estimating it could bring in over $12 billion in sales by the year 2030.

The applications for the new indication are backed by data from the placebo-controlled Phase III SELECT-GCA trial (NCT03725202). This study involved 438 participants who were administered either Rinvoq or a placebo in combination with corticosteroids. The trial achieved its primary endpoint by inducing remission in 46% of the participants treated with Rinvoq at 52 weeks, compared to a 29% remission rate in the placebo group.

Giant cell arteritis is an inflammatory disease that affects the blood vessels of the scalp, neck, and arms. It is a common type of vasculitis, particularly affecting people over 50 years of age, with an incidence rate of 18-29 cases per 100,000 individuals within this age group.

In addition to seeking approval for giant cell arteritis, AbbVie is also exploring the use of Rinvoq in treating hidradenitis suppurativa, a chronic inflammatory skin condition. A placebo-controlled Phase III trial (NCT05889182) is currently underway, evaluating Rinvoq in patients with moderate to severe forms of the disease who have not responded to anti-TNF therapy.

The versatility and efficacy of Rinvoq in treating multiple autoimmune and inflammatory conditions underscore its potential as a cornerstone therapy in AbbVie's portfolio. As the company continues to investigate and expand the therapeutic applications of Rinvoq, it is likely to solidify its standing as a leader in immunology treatments, while significantly boosting its revenue streams in the years to come.