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AbbVie (ABBV) Files for Rinvoq in Giant Cell Arteritis in US & EU
AbbVieAbbVie(US:ABBV) ZACKSยท2024-07-15 16:15

AbbVie Inc. (ABBV) announced that it has submitted regulatory applications to the FDA and the European Medicines Agency (EMA), seeking approval for its JAK inhibitor, Rinvoq (upadacitinib), for a new indication.The company is seeking approval for once-daily Rinvoq (15 mg) for treating adult patients with giant cell arteritis (GCA), an autoimmune disease-causing inflammation of the large arteries.The regulatory filings for GCA were based on data from the phase III SELECT-GCA study, which evaluated the safety ...