AbbVie has received the European Commission (EC) marketing authorisation for Rinvoq (upadacitinib) 15mg as a once-daily treatment for adults with giant cell arteritis (GCA).
Rinvoq, a selective and reversible JAK inhibitor that works by inhibiting JAK1 or JAK 1/3 signalling, with functional selectivity over cytokine receptors that signal via JAK2 pairs.
Discovered and developed by AbbVie scientists, Rinvoq is the first oral JAK inhibitor.
The drug is being studied in Phase 3 clinical trials for conditions including alopecia areata, hidradenitis suppurativa, systemic lupus erythematosus, Takayasu arteritis, and vitiligo.
The EC approval is valid in the European Union (EU), along with Iceland, Liechtenstein, and Norway, for treating adult patients with GCA.
GCA, also known as temporal arteritis, is an autoimmune disease that causes inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries.
The disease affects patients aged above 50 years, most commonly between 70 and 80 years, with symptoms such as headache, jaw pain, and vision changes or loss.
AbbVie chief scientific officer, research and development executive vice president Roopal Thakkar said: “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.
“This exciting milestone demonstrates our commitment to ongoing research and expanding indications in areas of high unmet need to help patients achieve better outcomes, including sustained disease remission.”
The EC approval is based on data from the Phase 3 SELECT-GCA trial, designed to evaluate the safety and efficacy of Rinvoq in 428 patients with GC.
The trial achieved primary and key secondary endpoints with Rinvoq 15mg and a 26-week steroid taper regimen compared to placebo with a 52-week steroid taper regimen.
The study results showed that 46.4% of patients receiving Rinvoq 15mg with a 26-week steroid taper achieved sustained remission at week 52, which is the primary endpoint.
Key secondary endpoints include a reduction in disease flares and a decrease in cumulative steroid exposure.
Rinvoq is also approved in the EU for the treatment of axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn’s disease, and atopic dermatitis.
SELECT-GCA trial investigator Wolfgang Schmidt said: “GCA is a challenging and often debilitating condition. Patients may endure headaches, jaw pain and muscle aches, with many fearing sudden and permanent vision loss.
“Results from the SELECT-GCA trial show that patients can achieve sustained remission and reduce their cumulative steroid exposure with Rinvoq, addressing important patient goals in the treatment of GCA.”
