U.S. FDA Approves Second Indication for SKYRIZI® (risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis

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

U.S. FDA Approves RINVOQ® (upadacitinib) to Treat Adults and Children 12 Years and Older with Refractory, Moderate to Severe Atopic Dermatitis

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

AbbVie Submits Applications for Upadacitinib (RINVOQ®) in Non-Radiographic Axial Spondyloarthritis to U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)

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.

RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Active Psoriatic Arthritis

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

Upadacitinib (RINVOQ®) Achieved Primary and Key Secondary Endpoints in First Phase 3 Induction Study in Patients with Crohn's Disease

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 

AbbVie Provides Update on RINVOQ® (upadacitinib) for the Treatment of Rheumatoid Arthritis in the U.S.

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

AbbVie Submits Application for Risankizumab (SKYRIZI®) in Moderate to Severe Crohn's Disease to European Medicines Agency (EMA)

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

New Literature Review Highlights Economic Benefits Associated with Achieving Rheumatoid Arthritis Remission

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

AbbVie Expands Immunology Portfolio in the European Union with the European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Adults with Active Psoriatic Arthritis

NORTH CHICAGO, Ill., Nov. 17, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved SKYRIZI® (risankizumab, 150 mg, subcutaneous injection at week 0, week 4 and every 12 weeks thereafter) alone or in combination with methotrexate (MTX), for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Marking the second indication for SKYRIZI, the Marketing Authorization will be valid in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland.

AbbVie Presents New Efficacy Data on Upadacitinib (RINVOQ®) in People with Active Psoriatic Arthritis and Axial Involvement at ACR Convergence 2021

NORTH CHICAGO, Ill., Nov. 9, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced results from new post-hoc analyses from the Phase 3 SELECT-PsA 1 and SELECT-PsA 2 trials assessing the efficacy of upadacitinib (RINVOQ®) on axial symptoms in adult patients with active psoriatic arthritis (PsA) and axial involvement. The analysis showed that patients with active PsA demonstrated numerically greater clinical responses related to their axial involvement with upadacitinib (15 mg, once daily) compared to placebo at week 24 across both studies and consistently numerically higher responses compared to HUMIRA® (adalimumab) at week 24 in SELECT-PsA 1.1