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Oct 29, 2021

AbbVie's Cariprazine (VRAYLAR®) Met Primary Endpoint in Phase 3 Study as an Adjunctive Treatment for Major Depressive Disorder

NORTH CHICAGO, Ill., Oct. 29, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced top-line results from two Phase 3 clinical trials, Study 3111-301-001 and Study 3111-302-001, evaluating the efficacy and safety of cariprazine (VRAYLAR®) as an adjunctive treatment for patients with major depressive disorder (MDD). In Study 3111-301-001, cariprazine showed a statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared with placebo. Patients treated with cariprazine at 1.5 mg/day achieved improved MADRS total score at week six compared to placebo (p-value=0.0050). Patients treated with cariprazine at 3.0 mg/day demonstrated improvement in MADRS total score at week six over placebo but did not meet statistical significance (p-value=0.0727). In Study 3111-302-001, cariprazine demonstrated numerical improvement in depressive symptoms from baseline to week six in MADRS total score compared with placebo but did not meet its primary endpoint for either the 1.5 mg/day or 3.0 mg/day dose.

Oct 29, 2021

AbbVie Reports Third-Quarter 2021 Financial Results

NORTH CHICAGO, Ill., Oct. 29, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the third quarter ended September 30, 2021.

Oct 28, 2021

AbbVie Announces ABBV-951 (Foslevodopa/Foscarbidopa) Showed Improvement in Controlling Motor Fluctuations Compared to Oral Levodopa/Carbidopa Medication in Pivotal Phase 3 Trial in Patients with Advanced Parkinson's Disease

NORTH CHICAGO, Ill., Oct. 28, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that continuous 24 hours/day subcutaneous infusion of ABBV-951 (foslevodopa/foscarbidopa) was statistically superior to oral levodopa/carbidopa in reducing motor fluctuations in patients with advanced Parkinson's disease (PD) in a Phase 3, randomized, double-blind, double-dummy, active-controlled study. The study met its primary endpoint of increase from baseline in "On" time (hours) without troublesome dyskinesia (involuntary movements) after 12 weeks based on the Parkinson's Disease Diary (PD Diary).1 These results will be a key component of global regulatory submissions.

Oct 26, 2021

Allergan, an AbbVie Company, to Present New Data on Investigational AGN-190584 for the Treatment of Presbyopia

NORTH CHICAGO, Ill., Oct. 26, 2021 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced that it will present new pooled analyses and post hoc results from the Phase 3 trials of AGN-190584 (pilocarpine HCl ophthalmic solution 1.25%), an investigational novel treatment for presbyopia, at Academy 2021, the annual meeting of the American Academy of Optometry, November 3-6. Presentations will include clinical results for near and intermediate vision, functional near vision, efficacy for post-LASIK patients, and the patient experience.

Oct 15, 2021

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.

Oct 11, 2021

Allergan Aesthetics Launches Series of Initiatives to Support Breast Cancer Awareness

IRVINE, Calif., Oct. 11, 2021 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is continuing its commitment to breast health, awareness, restoration, and research in support of breast cancer awareness month. For the month of October and into 2022, Allergan Aesthetics , The Power of You campaign will kick off a new series of initiatives and partnerships to support organizations creating a measurable impact in the fight against breast cancer.  

Oct 07, 2021

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

Oct 07, 2021

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 

Oct 05, 2021

AbbVie to Host Third-Quarter 2021 Earnings Conference Call

NORTH CHICAGO, Ill., Oct. 5, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) will announce its third-quarter 2021 financial results on Friday, October 29, 2021, before the market opens. AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time. It will be accessible through AbbVie's Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

Oct 02, 2021

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.