AbbVie seeks eighth indication for JAK inhibitor Rinvoq

AbbVie is poised to broaden the scope of its successful immunology drug, Rinvoq (upadacitinib), having recently submitted applications for approval to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The company seeks to have Rinvoq approved as a treatment for giant cell arteritis, an inflammatory condition affecting the blood vessels of the scalp, neck, and arms.

Rinvoq functions by inhibiting the activity of Janus kinase (JAK) enzymes within the JAK-STAT signaling pathway, which is crucial for the release of pro-inflammatory cytokines. The FDA has already given its nod to Rinvoq for seven autoimmune conditions, including atopic dermatitis, ankylosing spondylitis, axial spondylarthritis, Crohn’s disease, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

In terms of financial performance, Rinvoq stands out as one of AbbVie's top revenue generators, bringing in around $4 billion in sales last year. Projections suggest this figure will climb significantly, with expectations of exceeding $12 billion in sales by 2030, according to market analysis by GlobalData.

Supporting the regulatory submissions for Rinvoq is data derived 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's primary endpoint was achieved, with 46% of the participants in the Rinvoq treatment group reaching remission at 52 weeks, compared to a 29% remission rate in the placebo group.

Giant cell arteritis, the condition targeted in Rinvoq's latest application, is a common form of vasculitis mostly affecting individuals over the age of 50. It has an incidence rate ranging from 18 to 29 cases per 100,000 people in this age group.

Additionally, AbbVie is exploring the efficacy of Rinvoq in treating another chronic inflammatory condition—hidradenitis suppurativa. A placebo-controlled Phase III trial (NCT05889182) is currently underway to evaluate Rinvoq's effectiveness in patients with moderate to severe hidradenitis suppurativa who have not responded to anti-TNF therapy.

Rinvoq's potential new indications highlight AbbVie's commitment to expanding the therapeutic applications of its immunology portfolio. With robust clinical data backing its efficacy and safety, Rinvoq is poised to become an even more significant asset for AbbVie in the coming years.