AbbVie seeks expansion for blockbuster drug Rinvoq in Giant Cell Arteritis

USA—AbbVie Inc., an American pharmaceutical firm, has stated that it has filed regulatory applications with the FDA and the European Medicines Agency (EMA) for approval of its JAK inhibitor, Rinvoq (upadacitinib), for a new indication.

The company is seeking clearance for Rinvoq (15 mg) once daily to treat adult patients with giant cell arteritis (GCA), an inflammatory condition that causes inflammation of the major arteries.

Rinvoq inhibits the activity of Janus kinase (JAK) enzymes in the JAK-STAT signaling pathway, which is critical for producing pro-inflammatory cytokines.

 The FDA has already approved it to treat seven autoimmune disorders, including atopic dermatitis, ankylosing spondylitis, axial spondylarthritis, Crohn’s disease, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

The regulatory filings for GCA were based on phase III SELECT-GCA research results, which assessed Rinvoq’s safety and efficacy in GCA patients.

 This placebo-controlled trial (NCT03725202) 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.

Rinvoq’s regulatory submissions are bolstered by these promising results from the SELECT-GCA study, emphasizing its potential as a treatment for GCA.

 Moreover, according to the company’s financials, Rinvoq is already one of the top revenue-generating therapies for AbbVie, raking in approximately US$4 billion in sales last year.

Projections indicate that the therapy’s revenue is expected to soar over the next decade, with Rinvoq anticipated to generate over US$12 billion in sales by 2030, as per GlobalData market analysis.

Giant cell arteritis is an inflammatory condition affecting the scalp, neck, and arm blood vessels.

 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.

This condition can lead to severe complications, including vision loss and stroke, if not treated promptly and effectively.

In addition to its efforts in GCA, AbbVie is also investigating Rinvoq in adults and adolescents with hidradenitis suppurativa, a chronic inflammatory condition.

 A placebo-controlled Phase III trial (NCT05889182) is currently evaluating Rinvoq in patients with moderate to severe hidradenitis suppurativa who have failed anti-TNF therapy.

This ongoing research underscores AbbVie’s commitment to expanding Rinvoq’s therapeutic applications and addressing unmet medical needs across various inflammatory conditions.

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