The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AbbVie’s upadacitinib (Rinvoq) to treat adults with giant cell arteritis (GCA).
The recommendation brings the therapy closer to becoming the first oral advanced treatment for GCA, with the European Commission’s final decision anticipated in the first half of 2025.
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AbbVie immunology clinical development global head and vice-president Kori Wallace stated: “The CHMP’s positive opinion for upadacitinib for adults living with giant cell arteritis is an important step toward our goal of improving outcomes for patients suffering with this disease.
“We are committed to advancing the standards of care for immune-mediated diseases and addressing unmet patient needs, today and in the future.”
The CHMP’s endorsement is based on outcomes from the pivotal Phase III SELECT-GCA trial, which assessed the safety and efficacy of the therapy in individuals aged 50 and above with GCA.
Subjects were randomised in the first study period, to receive a 7.5 mg or 15 mg dose of the therapy plus a 26-week corticosteroid taper regimen, or a placebo with a 52-week corticosteroid taper schedule.
Throughout the 52-week, placebo-controlled period, upadacitinib’s safety profile remained generally consistent with that observed in other indications that are approved.
The treatment has gained approval in the European Union (EU) for a range of conditions, including psoriatic arthritis, rheumatoid arthritis and Crohn’s disease, but its use for GCA is still pending approval.
Also referred to as temporal arteritis, GCA is an autoimmune condition affecting medium and large arteries.
Discovered and developed by the company’s scientists, Rinvoq is a selective and reversible Janus kinase inhibitor under investigation for various immune-mediated inflammatory conditions.
Further Phase III trials are exploring the therapy’s potential in conditions such as alopecia areata, vitiligo and systemic lupus erythematosus.
In May 2024, the CHMP granted a positive recommendation for AbbVie’s ulcerative colitis drug Skyrizi (risankizumab).
