AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in giant cell arteritis

AbbVie

12 July 2024 - Submissions are supported by the Phase 3 SELECT-GCA study demonstrating upadacitinib 15 mg with a 26 week steroid taper regimen achieved the primary endpoint of sustained remission from week 12 through week 52.

AbbVie today announced that it has submitted applications for a new indication to the US FDA and EMA for upadacitinib (Rinvoq 15 mg, once daily) for the treatment of adult patients with giant cell arteritis.

Read AbbVie press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , US , Dossier