HUMIRA® (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis

NORTH CHICAGO, Ill., Feb. 24, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved HUMIRA® (adalimumab) for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. In clinical trials, HUMIRA induced clinical remission at Week 8 and maintained remission at Week 52 in patients who responded at Week 8.1,2

Second Phase 3 Induction Study Confirms Upadacitinib (RINVOQ™) Improved Clinical, Endoscopic and Histologic Outcomes in Ulcerative Colitis Patients

NORTH CHICAGO, Ill., Feb. 22, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all ranked secondary endpoints in the Phase 3 induction study, U-ACCOMPLISH.1 In the study, 33 percent of patients receiving upadacitinib achieved clinical remission (per Adapted Mayo Score) at week 8 compared to 4 percent of patients receiving placebo (p<0.001).1 U-ACCOMPLISH is the second of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe ulcerative colitis.1

European Commission Approves AbbVie's RINVOQ™ (Upadacitinib) for the Treatment of Psoriatic Arthritis and Ankylosing Spondylitis

NORTH CHICAGO, Ill., Jan. 25, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV), today announced that the European Commission (EC) has approved RINVOQTM (upadacitinib, 15 mg), an oral, once daily selective and reversible JAK inhibitor for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate. RINVOQ is also indicated for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy.1 The EC approval is supported by data from the three pivotal clinical trials SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1, demonstrating RINVOQ's efficacy across multiple measures of disease activity.* 4-6

Risankizumab (SKYRIZI®) Demonstrates Significant Improvements in Clinical Remission and Endoscopic Response in Two Phase 3 Induction Studies in Patients with Crohn's Disease

NORTH CHICAGO, Ill., Jan. 7, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive results from two Phase 3 induction studies, ADVANCE and MOTIVATE, showing both doses of risankizumab (600 mg and 1200 mg) met both primary endpoints of clinical remission and endoscopic response at week 12 in adult patients with moderate to severe Crohn's disease.1,2 The ADVANCE study enrolled patients who had an inadequate response or were intolerant to conventional and/or biologic therapy.1 The MOTIVATE study evaluated patients who had responded inadequately or were intolerant to biologic therapy.2

Risankizumab (SKYRIZI®) Phase 3 Results Demonstrate Improvements in Disease Activity Across Joint and Skin Symptoms Among Psoriatic Arthritis Patients

NORTH CHICAGO, Ill., Jan. 5, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive top-line results from two Phase 3 studies in adults with active psoriatic arthritis, KEEPsAKE-1 and KEEPsAKE-2, showing that significantly more patients treated with risankizumab (150 mg) achieved the primary endpoint of ACR20 response at week 24 versus placebo.1 In KEEPsAKE-1 and KEEPsAKE-2, 57 and 51 percent of patients receiving risankizumab achieved ACR20 response at week 24, respectively, versus 34 and 27 percent receiving placebo (p<0.001).1

CHMP Recommends the Approvals of RINVOQ™ (Upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis and Ankylosing Spondylitis

NORTH CHICAGO, Ill., Dec. 11, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of RINVOQ (upadacitinib, 15 mg), an oral, once daily selective and reversible JAK inhibitor, for the expanded use in two additional rheumatic indications: the treatment of adult patients with active psoriatic arthritis and adult patients with active ankylosing spondylitis.5 The CHMP positive opinions are based on results from three pivotal clinical studies in which RINVOQ demonstrated efficacy across multiple measures of disease activity.1-3

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., Dec. 10, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced top-line results from the Phase 3b Heads Up study showing that upadacitinib (30 mg, once daily) achieved superiority to dupilumab (300 mg, every other week) for the primary endpoint, the proportion of patients with at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) at week 16, in adults with moderate to severe atopic dermatitis.1 Of patients treated with upadacitinib, 71 percent achieved EASI 75 at week 16 compared to 61 percent of dupilumab-treated patients (p=0.006).1 Upadacitinib also showed superiority compared to dupilumab for all ranked secondary endpoints, including additional measures of skin clearance and itch reduction.1

Upadacitinib (RINVOQ™) Meets Primary and All Ranked Secondary Endpoints in First Phase 3 Induction Study in Ulcerative Colitis

NORTH CHICAGO, Ill., Dec. 9, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive results from the Phase 3 induction study, U-ACHIEVE, which showed upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 8, as well as all ranked secondary endpoints, in adult patients with moderate to severe ulcerative colitis.1 In the study, 26 percent of patients receiving upadacitinib achieved clinical remission compared to 5 percent of patients receiving placebo (p<0.001).1 U-ACHIEVE is the first of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe ulcerative colitis.1

AbbVie Submits Regulatory Application to FDA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Ankylosing Spondylitis

NORTH CHICAGO, Ill., Aug. 25, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for RINVOQ™ (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active ankylosing spondylitis. AbbVie also submitted an application to the European Medicines Agency (EMA) for RINVOQ earlier this year for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.

Third Pivotal Phase 3 Study Shows RINVOQ™ (upadacitinib) Plus Topical Corticosteroids Improves Skin and Itch Symptoms in Atopic Dermatitis Patients

NORTH CHICAGO, Ill., July 28, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced upadacitinib (15 mg and 30 mg, once daily) plus topical corticosteroids (TCS) met the co-primary endpoints and all secondary endpoints in AD Up, the third pivotal Phase 3 study of RINVOQ in atopic dermatitis.1 AD Up evaluated the efficacy and safety of both doses of upadacitinib therapy versus placebo in adults and adolescents with moderate to severe atopic dermatitis; all treatment groups, including placebo, received concomitant TCS.1 The co-primary endpoints were at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) from baseline and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16.1