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

SKYRIZI® (risankizumab-rzaa) Now Available in the U.S. as a Single 150 mg Injection for Adults with Moderate to Severe Plaque Psoriasis

NORTH CHICAGO, Ill., Aug. 9, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that SKYRIZI® (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, is now available in the U.S. as a single-dose 150 mg injection for the treatment of adults with moderate to severe plaque psoriasis. Previously two 75 mg injections per dose, SKYRIZI 150 mg is now administered with one injection per dose – via either a prefilled pen or syringe – every 12 weeks following two starter doses.1

JAMA Dermatology Publishes Data Showing RINVOQ® (upadacitinib) Achieved Superiority Versus DUPIXENT® (dupilumab) for Primary and All Ranked Secondary Endpoints in Phase 3b Head-to-Head Study in Adults with Atopic Dermatitis

NORTH CHICAGO, Ill., Aug. 4, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that JAMA Dermatology has published 24-week results from the Phase 3b Heads Up study evaluating the efficacy and safety of RINVOQ® (upadacitinib, 30 mg, once daily) versus DUPIXENT® (dupilumab, 300 mg, every other week) – both as monotherapy treatments – in adults with moderate to severe atopic dermatitis who were candidates for systemic therapy.

AbbVie Provides Update Regarding RINVOQ® (upadacitinib) for the Treatment of Moderate to Severe Atopic Dermatitis in the U.S.

NORTH CHICAGO, Ill., July 16, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) did not meet the Prescription Drug User Fee Act (PDUFA) action date for the supplemental New Drug Application (sNDA) for RINVOQ® (upadacitinib) for the treatment of adults and adolescents with moderate to severe atopic dermatitis.

Upadacitinib (RINVOQ®) Met the Primary and All Secondary Endpoints in the 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients

NORTH CHICAGO, Ill., June 29, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that upadacitinib (15 mg or 30 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all secondary endpoints at one-year (week 52) in the Phase 3 ulcerative colitis maintenance study.1 Significantly more upadacitinib-treated patients achieved clinical remission at week 52 compared to placebo (15 mg: 42 percent and 30 mg: 52 percent versus placebo: 12 percent; p<0.001).1

AbbVie Gastroenterology Pipeline to be Featured at the 16th Congress of European Crohn's and Colitis Organisation (ECCO)

NORTH CHICAGO, Ill., June 28, 2021 /PRNewswire/ -- AbbVie today announced new data on upadacitinib (RINVOQ®) in ulcerative colitis and risankizumab (SKYRIZI®) in Crohn's disease will be presented as oral presentations at the 16th Congress of European Crohn's and Colitis Organisation (ECCO), to be held virtually July 2-3 and July 8-10. AbbVie is presenting a total of nine abstracts, five of which are oral presentations, across a broad range of studies in inflammatory bowel diseases (IBD).

AbbVie Provides Update Regarding RINVOQ® (upadacitinib) in Psoriatic Arthritis and Ankylosing Spondylitis in the U.S.

NORTH CHICAGO, Ill., June 25, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has informed the company that the FDA will not meet the Prescription Drug User Fee Act (PDUFA) action dates for the supplemental New Drug Applications (sNDAs) for RINVOQ® (upadacitinib) for the treatment of adults with active psoriatic arthritis and adults with active ankylosing spondylitis. The FDA cited its ongoing review of Pfizer's post-marketing study, ORAL Surveillance, evaluating tofacitinib in patients with rheumatoid arthritis.

CHMP Recommends Approval of RINVOQ® (upadacitinib) for the Treatment of Atopic Dermatitis

NORTH CHICAGO, Ill., June 25, 2021 /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 RINVOQ® (upadacitinib), an oral, selective and reversible JAK inhibitor, for the expanded use in adults (15 mg or 30 mg, once daily) and adolescents 12 years and older (15 mg, once daily) with moderate to severe atopic dermatitis who are candidates for systemic therapy. RINVOQ is being studied in several immune-mediated inflammatory diseases.4-10