The European Commission (EC) has granted marketing authorisation for AbbVie’s once-a-day treatment Rinvoq (upadacitinib) 15mg for adults with giant cell arteritis (GCA).
It is the first and only oral Janus kinase inhibitor approved in the European Union, Liechtenstein, Norway and Iceland, for this indication.
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GCA is an autoimmune condition, predominantly affecting individuals over 50, with the highest incidence between 70 and 80 years of age.
The condition leads to the inflammation of the aorta, the temporal and cranial arteries, and other large and medium arteries.
The authorisation of Rinvoq is based on data from the multicentre Phase III SELECT-GCA trial, which was structured to assess the efficacy and safety of the therapy in 428 GCA subjects.
The trial met its primary and key secondary endpoints, demonstrating that 46.4% of subjects treated with 15 mg of the therapy plus a steroid taper regimen for 26 weeks achieved sustained remission at week 52 versus 29% of those on placebo with a steroid taper regimen.
AbbVie research and development, chief scientific officer and executive vice-president Roopal Thakkar stated: “The EC approval of Rinvoq in GCA provides patients and physicians with a new treatment option and the first oral advanced therapy for adults living with GCA – a particularly vulnerable population due to older age and frequent comorbidities.”
The therapy has previously gained approval in the EU for conditions including psoriatic arthritis, radiographic axial spondylarthritis and Crohn’s disease.
Rinvoq has been discovered and developed by company scientists and is currently under investigation for other immune-mediated inflammatory conditions.
It is also undergoing Phase III trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, vitiligo and systemic lupus erythematosus.
In March 2025, the company announced a $2.3bn licensing agreement to acquire global rights to the long-acting amylin analogue, GUB014295, from Danish biotech Gubra.
