The US Food and Drug Administration (FDA) has granted approval for AbbVie’s 15mg Rinvoq (upadacitinib) to treat adults with giant cell arteritis (GCA).
The approval follows the recent marketing authorisation granted by the European Commission for the same treatment in adult patients.
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The approval of this one-time-a-day treatment for GCA is backed by the outcomes of the randomised Phase III SELECT-GCA trial.
The trial achieved its primary endpoint, with 46.4% of subjects on the 15mg of the therapy and a 26-week steroid taper regimen reaching sustained remission from week 12 to week 52, in contrast to 29.0% on a placebo and a 52-week steroid taper regimen.
Throughout the 52-week, placebo-controlled period of the trial, the therapy’s safety profile was found to be generally consistent with that seen in other approved indications.
AbbVie research and development chief scientific officer and executive vice-president Roopal Thakkar said: “This FDA approval will now provide an alternative treatment option that can offer patients with GCA the possibility of tapering off steroids and achieving sustained remission.
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By GlobalData“With this new indication for Rinvoq, we are underscoring AbbVie’s commitment to exploring how we can identify and address unmet needs for patients with immune-mediated diseases.”
Also referred to as temporal arteritis, GCA is stated to be an autoimmune condition affecting medium and large-sized arteries, marked by the granulomatous inflammation of the three-layered vessel wall.
This condition can cause serious complications such as an aortic aneurysm, stroke, or blindness if not treated.
Developed by the scientists of the company, this Janus kinase (JAK) inhibitor is under investigation for various immune-mediated inflammatory conditions.
The therapy is currently undergoing Phase III trials for multiple conditions, including hidradenitis suppurativa, vitiligo, Takayasu arteritis, alopecia areata, and systemic lupus erythematosus.
In March, the company announced a $2.3bn licensing agreement to acquire global rights to the long-acting amylin analogue, GUB014295, from Danish company Gubra.
