NORTH CHICAGO, Ill., Feb. 24, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive top-line results from U-EXCEL, a Phase 3 induction study, showing upadacitinib (45 mg once daily) achieved both primary endpoints of clinical remissiona,b and endoscopic responsec at week 12.1 U-EXCEL is the second of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe Crohn's disease who had an inadequate response or were intolerant to conventional or biologic therapy.1

NORTH CHICAGO, Ill., Feb. 1, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) will present further analyses on HUMIRA® (adalimumab) and the investigational uses of risankizumab (SKYRIZI®) and upadacitinib (RINVOQ®) at the 17th Congress of European Crohn's and Colitis Organisation (ECCO), to be held February 16-19. AbbVie will present 26 abstracts, including 8 oral presentations, 8 digital oral presentations and 10 posters from a broad range of studies across its inflammatory bowel disease (IBD) portfolio.

NORTH CHICAGO, Ill., Jan. 21, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts approximately 30 percent of patients with psoriasis.1,4-7

NORTH CHICAGO, Ill., Jan. 14, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended.1 RINVOQ 15 mg once daily can be initiated in adults and children 12 years of age and older weighing at least 40 kg.1 In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily.1

NORTH CHICAGO, Ill., Jan. 7, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted applications seeking approvals for upadacitinib (RINVOQ®, 15 mg once daily) to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). The applications are supported by the Phase 3 SELECT-AXIS 2 (Study 2) clinical trial.

NORTH CHICAGO, Ill., Dec. 14, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment of adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.1

NORTH CHICAGO, Ill., Dec. 6, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive top-line results from U-EXCEED, a Phase 3 induction study, showing upadacitinib (45 mg once daily) achieved both primary endpoints of clinical remissiona,b and endoscopic responsec at week 12.1 The U-EXCEED study enrolled patients with moderate to severe Crohn's disease who had an inadequate response or were intolerant to biologic therapy, with over 60 percent having previously failed two or more biologics.1 U-EXCEED is the first of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe Crohn's disease.1 

NORTH CHICAGO, Ill., Dec. 3, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced an update to the U.S. Prescribing Information and Medication Guide for RINVOQ® (upadacitinib) for the treatment of adults with moderate to severe rheumatoid arthritis (RA). This update follows a Drug Safety Communication (DSC) issued on Sept. 1, 2021 by the U.S. Food and Drug Administration (FDA) following its final review of the post-marketing study, ORAL Surveillance, evaluating XELJANZ® (tofacitinib) in patients with RA.1 The results of this study showed a higher rate of major adverse cardiac events (MACE), malignancy, mortality and thrombosis in XELJANZ (a Janus kinase (JAK) inhibitor) versus TNF blockers.1 The DSC and this label update apply to the class of systemically administered FDA-approved JAKs indicated for the treatment of RA and other inflammatory diseases.1

NORTH CHICAGO, Ill., Nov. 30, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced it has submitted an application to the European Medicines Agency (EMA) seeking approval for risankizumab (SKYRIZI®, 600 mg intravenous (IV) induction and 360 mg subcutaneous (SC) maintenance therapy), an interleukin-23 (IL-23) inhibitor, for the treatment of patients 16 years and older with moderate to severe active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. The submission is supported by three pivotal Phase 3 studies, ADVANCE, MOTIVATE and FORTIFY.1,2

NORTH CHICAGO, Ill., Nov. 18, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the publication of results from a new literature review in Advances in Therapy. The literature review reported that achieving clinical remission in rheumatoid arthritis (RA) is likely to be associated with economic benefits, such as reduced direct and indirect disease-related medical costs compared with other disease activity levels.1