AbbVie Receives CHMP Positive Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults with Active Psoriatic Arthritis in the European Union (EU)

NORTH CHICAGO, Ill., Oct. 15, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of risankizumab (SKYRIZI®, 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 antirheumatic drugs (DMARDs). The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission, which authorizes marketing approval in the European Union.

AbbVie's RINVOQ® (upadacitinib) Met Primary and All Ranked Secondary Endpoints in Phase 3 Study in Ankylosing Spondylitis

NORTH CHICAGO, Ill., Oct. 7, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive top-line results from the first of two studies of the Phase 3 SELECT-AXIS 2 clinical trial evaluating the efficacy and safety of RINVOQ® (upadacitinib; 15 mg, once daily) in patients with active ankylosing spondylitis (AS) who had an inadequate response to biologic DMARD therapy. In this study, RINVOQ met its primary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 40 response and all ranked secondary endpoints at week 14.1 Significantly more RINVOQ-treated patients achieved ASAS40 response at week 14 compared to placebo (45 percent versus 18 percent; p<0.0001).1

AbbVie's Upadacitinib (RINVOQ®) Met Primary and Most Ranked Secondary Endpoints in Phase 3 Study for Non-Radiographic Axial Spondyloarthritis

NORTH CHICAGO, Ill., Oct. 7, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive top-line results from Study 2 of the Phase 3 SELECT-AXIS 2 clinical trial in adults with active non-radiographic axial spondyloarthritis (nr-axSpA), showing upadacitinib (RINVOQ®; 15 mg, once daily) met the primary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 40 response and the majority of ranked secondary endpoints at week 14.1 Significantly more upadacitinib-treated patients achieved ASAS40 response at week 14 compared to placebo (45 percent versus 23 percent; p<0.0001).1 

AbbVie to Showcase New Data at the United European Gastroenterology (UEG) Week Virtual 2021

NORTH CHICAGO, Ill., Oct. 2, 2021 /PRNewswire/ -- AbbVie today announced new data on the investigational use of risankizumab (SKYRIZI®) in Crohn's disease, upadacitinib (RINVOQ®) in ulcerative colitis and HUMIRA® (adalimumab) in inflammatory bowel disease (IBD) will be presented as live presentations and e-Posters at the United European Gastroenterology (UEG) Week Virtual 2021, to be held October 3-5. AbbVie is presenting a total of 13 abstracts, across a broad range of studies in IBD, including two late-breaking maintenance studies evaluating the efficacy and safety of risankizumab in Crohn's disease and upadacitinib in ulcerative colitis at 52 weeks.

AbbVie Presents Late-Breaking Data on Risankizumab (SKYRIZI®) in Psoriatic Arthritis at the 30th European Academy of Dermatology and Venereology (EADV) Congress

NORTH CHICAGO, Ill., Sept. 30, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today presented results from new Phase 3 data analyses of KEEPsAKE-1 and KEEPsAKE-2, evaluating risankizumab (SKYRIZI®, 150 mg) in adults with active psoriatic arthritis for one year (52 weeks).1 These results were featured during the "Late Breaking News, Reviews and Updates" session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.

AbbVie Presents New Analyses Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis Across Patient Characteristics and Body Regions at EADV Virtual Congress

NORTH CHICAGO, Ill., Sept. 30, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new analyses from the Phase 3 RINVOQ® (upadacitinib) atopic dermatitis clinical trial program to be presented at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress. One analysis showed a greater proportion of patients treated with RINVOQ (15 mg or 30 mg; once daily) with or without topical corticosteroids achieved 75 percent improvement in the Eczema Area Severity Index (EASI 75) at week 16 compared to placebo, regardless of age, sex, race, weight, disease severity and previous exposure to systemic therapy.1 An additional analysis showed more patients treated with RINVOQ 30 mg achieved EASI 75 at week 16 compared to dupilumab when measured in four body regions.2

AbbVie Presents New Data Analyses for Growing Dermatology Portfolio at the 30th European Academy of Dermatology and Venereology (EADV) Congress

NORTH CHICAGO, Ill., Sept. 23, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will present 27 abstracts across its dermatology portfolio, including new analyses evaluating the safety and efficacy of RINVOQ® (upadacitinib) in atopic dermatitis and new data on SKYRIZI® (risankizumab) in psoriasis and psoriatic arthritis, at the 30th European Academy of Dermatology and Venereology (EADV) Congress, to be held virtually on September 29-October 2.

AbbVie Submits Regulatory Application to FDA for Risankizumab-rzaa (SKYRIZI®) for the Treatment of Patients 16 Years and Older with Moderate to Severe Crohn's Disease

NORTH CHICAGO, Ill., Sept. 20, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for risankizumab-rzaa (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 Crohn's disease. The submission is supported by safety and efficacy data from three Phase 3 studies – ADVANCE, MOTIVATE and FORTIFY.

AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

NORTH CHICAGO, Ill., Sept. 16, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg (maintenance dose) and 45 mg (induction dose)) for the treatment of adults with moderately to severely active ulcerative colitis to the U.S. Food and Drug Administration (FDA), and to the European Medicines Agency (EMA) for the treatment of adults with moderately to severely active ulcerative colitis, who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

European Commission Approves RINVOQ® (upadacitinib) as First JAK Inhibitor in the European Union for the Treatment of Both Adults and Adolescents with Moderate to Severe Atopic Dermatitis

NORTH CHICAGO, Ill., Aug. 24, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the European Commission (EC) approved RINVOQ® (upadacitinib), an oral, selective and reversible JAK inhibitor, for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.1 The recommended dose of RINVOQ for atopic dermatitis in adults is 15 mg or 30 mg once daily based on individual patient presentation, and 15 mg once daily for adolescents (12-17 years of age) and adults 65 years and older.1 RINVOQ can be used with or without topical corticosteroids (TCS).1