CHMP Recommends Approval of Upadacitinib (RINVOQ®) for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis

NORTH CHICAGO, Ill., June 27, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of upadacitinib (RINVOQ® 15 mg, once daily) for the treatment of active non-radiographic axial spondyloarthritis (nr‑axSpA) in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).*

SKYRIZI® (risankizumab-rzaa) Receives FDA Approval as the First and Only Specific Interleukin-23 (IL-23) to Treat Moderately to Severely Active Crohn's Disease in Adults

- Third approved indication for SKYRIZI (risankizumab-rzaa) is supported by safety and efficacy data from two induction and one maintenance clinical trials evaluating SKYRIZI in moderately to severely active Crohn's disease, ADVANCE, MOTIVATE and FORTIFY1-4

AbbVie Presents Positive Results from Phase 3 SELECT-AXIS 2 Trials of Upadacitinib (RINVOQ®) in Patients with Axial Spondyloarthritis at EULAR 2022

NORTH CHICAGO, Ill., June 1, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the presentation of full results from two studies from the Phase 3 SELECT-AXIS 2 program evaluating upadacitinib (RINVOQ®), an oral therapy, in adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) and patients with treatment-refractory active ankylosing spondylitis (AS) with an inadequate response (IR) to biologic disease-modifying antirheumatic drugs (bDMARDs). Both studies met the primary endpoint of Assessment of SpondyloArthritis international Society 40 percent response criteria (ASAS40) at week 14 versus placebo.1,2 

The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Upadacitinib (RINVOQ®) in Ulcerative Colitis

NORTH CHICAGO, Ill., May 27, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced The Lancet published results from three pivotal Phase 3 clinical trials – U-ACHIEVE (induction), U-ACCOMPLISH and U-ACHIEVE (maintenance) – evaluating upadacitinib (RINVOQ®) in patients with moderately to severely active ulcerative colitis who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.

The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Risankizumab (SKYRIZI®) in Crohn's Disease

NORTH CHICAGO, Ill., May 27, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced The Lancet published results from three pivotal Phase 3 clinical trials – ADVANCE, MOTIVATE (induction studies) and FORTIFY (maintenance study) – evaluating risankizumab (SKYRIZI®) in patients with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.

AbbVie Showcases its Leadership in Rheumatology Research with New Data Across Multiple Inflammatory Joint Diseases at the EULAR 2022 Congress

- SELECT-AXIS 2 highlights the efficacy and safety data of upadacitinib (RINVOQ®) in patients with non-radiographic axial spondyloarthritis, and in patients with radiographic axial spondyloarthritis (ankylosing spondylitis) with an inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs)
- SELECT-PsA 1 & 2 highlight the efficacy and safety data of RINVOQ at two years in psoriatic arthritis (PsA) patients with an inadequate response or intolerance to ≥1 non-biologic DMARD, and in PsA patients with prior inadequate response or intolerance to ≥1 bDMARD, respectively
- KEEPsAKE 1 & 2 trials showcase the efficacy and safety data of SKYRIZI ® (risankizumab) in patients with active PsA

CHMP Recommends European Commission Approval of Upadacitinib (RINVOQ®) for the Treatment of Adults with Moderate to Severe Ulcerative Colitis

NORTH CHICAGO, Ill., May 23, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®, 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.*

AbbVie to Showcase Depth of Gastroenterology Portfolio and Pipeline at Digestive Disease Week®

NORTH CHICAGO, Ill., May 16, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that 27 abstracts across its gastroenterology portfolio will be presented at the Digestive Disease Week (DDW) Annual Meeting, May 21-24, 2022, in San Diego and virtually.

AbbVie and Cugene Announce Collaboration in Autoimmune Diseases

- AbbVie receives the option to license worldwide rights to CUG252 from Cugene, a clinical-stage and potential best-in-class Treg-selective IL-2 mutein, building on AbbVie's commitment to developing novel therapies in immunology

AbbVie Awards 45 Scholarships to U.S. Students Living with Chronic, Immune-Mediated Diseases in Their Pursuit of Higher Education

NORTH CHICAGO, Ill., May 12, 2022 /PRNewswire/ -- AbbVie today announced the 2022-2023 class of recipients of the AbbVie Immunology Scholarship, which provides financial support to students living with chronic, immune-mediated diseases pursuing higher education in the United States. As part of AbbVie's leadership and commitment to the immunology community, the scholarship seeks to empower students as they pursue a degree and a life not defined by their diseases.