NORTH CHICAGO, Ill., March 23, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced topline results from a Phase 2 study of upadacitinib (RINVOQ®, 30 mg) given alone or as combination therapy (ABBV-599) with a Bruton's Tyrosine Kinase inhibitor (elsubrutinib, 60 mg), once daily in patients with moderately to severely active systemic lupus erythematosus (SLE).1 The SLEek study met the primary endpoint of SLE Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day at week 24 in the upadacitinib 30 mg group.1,2 Based on the results, AbbVie is advancing its clinical program of upadacitinib in SLE to Phase 3.
NORTH CHICAGO, Ill., March 23, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive top-line results from INSPIRE, a Phase 3 induction study, showing risankizumab (SKYRIZI®,1200 mg intravenous [IV], at weeks 0, 4 and 8) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 12, as well as all secondary endpoints in adult patients with moderately to severely active ulcerative colitis.1 In the study, 20.3% of patients receiving risankizumab achieved clinical remission compared to 6.2% of patients receiving placebo (p<0.00001).1 The INSPIRE study enrolled patients that demonstrated intolerance or inadequate response to conventional therapies and/or advanced therapies (biologics, JAK inhibitors and S1P receptor modulators).1
NORTH CHICAGO, Ill., March 18, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new 52-week data from an open-label, single-arm study demonstrating improved plaque psoriasis signs and symptoms among a difficult-to-treat patient population who received SKYRIZI® (risankizumab), an IL-23 inhibitor. These moderate to severe plaque psoriasis patients previously had a suboptimal response to treatment with secukinumab or ixekizumab, both IL-17A inhibitor therapies, for at least six months before switching to risankizumab. The data were presented at a Late-Breaking Research session during the 2023 American Academy of Dermatology (AAD) Annual Meeting in New Orleans, Louisiana.
- More than 20 abstracts, including one late-breaking presentation, underscore AbbVie's dedication to advancing care for dermatologic conditions
NORTH CHICAGO, Ill., Feb. 27, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) will present further analyses on SKYRIZI® (risankizumab) in Crohn's disease (CD) and RINVOQ® (upadacitinib) in ulcerative colitis (UC) as well as the investigational use of upadacitinib in CD at the 18th Congress of European Crohn's and Colitis Organisation (ECCO), to be held March 1-4 in Copenhagen, Denmark. AbbVie will present 24 abstracts, including four oral presentations, two digital oral presentations and 18 posters from a broad range of studies across its inflammatory bowel disease (IBD) portfolio.
NORTH CHICAGO, Ill., Feb. 27, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of upadacitinib (RINVOQ®, 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.1-4
NORTH CHICAGO, Ill., Dec. 16, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted a supplemental New Drug Application (sNDA) for linaclotide (LINZESS®) to the U.S. Food and Drug Administration (FDA) for the treatment of children and adolescents 6 to 17 years of age with functional constipation (FC). The sNDA submission is based on results from a Phase 3 clinical trial, which met the primary and secondary endpoints, evaluating linaclotide (72 mcg) for increased frequency of spontaneous bowel movements (SBM) and improvement in stool consistency in patients aged 6 to17 years. LINZESS is developed and marketed by AbbVie and Ironwood Pharmaceuticals in the United States and is currently indicated for the treatment of adults with chronic idiopathic constipation (CIC) or irritable bowel syndrome with constipation (IBS-C).
- Third approved indication for SKYRIZI® (risankizumab) and the first specific IL-23 inhibitor for the treatment of Crohn's disease in the European Union (EU)
- A significantly higher proportion of patients on SKYRIZI achieved clinical remission, endoscopic response, mucosal healing and endoscopic remission at week 12 in induction studies compared to placebo1,2,3
- A significantly higher proportion of patients achieved clinical remission and endoscopic response at week 52 with SKYRIZI maintenance1,2,3
- Crohn's disease is a chronic, systemic inflammatory disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea, abdominal pain and can require urgent medical care4,5,6
NORTH CHICAGO, Ill., Nov. 21, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application for epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody, for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
NORTH CHICAGO, Ill., Nov. 8, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it would present new data across its rheumatology portfolio, including RINVOQ® (upadacitinib) for rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, and SKYRIZI® (risankizumab) for psoriasis and psoriatic arthritis at the American College of Rheumatology's annual meeting (ACR Convergence 2022) taking place November 10-14 in Philadelphia, PA, as well as virtually.
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