The European Commission has granted marketing authorization to AbbVie’s Rinvoq for the treatment of giant cell arteritis (GCA), marking the first and only oral JAK inhibitor approved in the EU, as well as Iceland, Liechtenstein and Norway, for the treatment of adult patients with GCA.
GCA is an autoimmune disease that causes inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries. GCA generally impacts patients older than 50 years, most commonly between the ages of 70 and 80 years.
The EC approval is supported by data from the phase 3 SELECT-GCA trial, which was recently published in the New England Journal of Medicine. In the trial, primary and key secondary endpoints were achieved with Rinvoq 15 mg and a 26-week steroid taper regimen compared to placebo in combination with a 52-week steroid taper regimen. 46.4% of patients receiving Rinvoq 15 mg in combination with a the steroid taper regimen achieved sustained remission at week 52, compared with 29% of patients receiving placebo in combination with the steroid taper regimen.
This is the eight indication for Rinvoq, which is already approved for seven immune-mediated inflammatory diseases in several countries, including the U.S. and the EU. Indications are radiographic axial spondylarthritis, nonradiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease and atopic dermatitis.