NORTH CHICAGO, Ill., Sept. 29, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today revealed the spectrum of new data from studies of risankizumab (SKYRIZI®) in Crohn's disease and upadacitinib (RINVOQ®) in ulcerative colitis and Crohn's disease that will be presented as live presentations and e-Posters at the United European Gastroenterology (UEG) Week 2022, October 8-11 in Vienna and online. In total, AbbVie is presenting 17 abstracts across a broad range of studies in inflammatory bowel disease (IBD).
- CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one for maintenance1,2
- Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea, abdominal pain and can require urgent medical care3,4
- If approved, risankizumab will be the first specific IL-23 inhibitor for the treatment of Crohn's disease in the European Union (EU)
- The European Commission decision is expected in the fourth quarter of 2022. This anticipated approval would mark the third indication for risankizumab in the EU
- Analyses included 100-week efficacy and safety data from the four-year, open-label extension period of KEEPsAKE 1 and 2 evaluating SKYRIZI in patients with active psoriatic arthritis1
NORTH CHICAGO, Ill., Sept. 8, 2022 /PRNewswire/ -- An analysis from AbbVie's (NYSE: ABBV) three-year, 28-country MEASURE-AD study revealed that people living with moderate to severe atopic dermatitis (an immune-mediated skin disease) who are not receiving systemic therapy had greater clinical, psychosocial and economic burdens compared to those receiving systemic therapy.1 A separate analysis from the MEASURE-AD study demonstrated that better quality of life – as measured by Dermatology Life Quality Index (DLQI) scores – and lower disease severity scores were associated with lower clinical burden and work impairment.2 Results from the MEASURE-AD subanalyses were featured at the 31st European Academy of Dermatology and Venereology (EADV) Hybrid Congress onsite in Milan and online from September 7-10 as a poster and an oral presentation.
NORTH CHICAGO, Ill., Aug. 29, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will present 23 abstracts at the 31st European Academy of Dermatology and Venereology (EADV) Congress, including a late-breaking oral presentation on long-term efficacy and safety data of SKYRIZI® (risankizumab) in psoriatic arthritis and real-world data from MEASURE-AD to assess the multidimensional burden of atopic dermatitis. This research demonstrates AbbVie's commitment to deepening the understanding of immune-mediated skin diseases by investing in studies of difficult-to-treat patient populations, certain disease areas with few existing treatment options as well as real-world patient experience. The hybrid congress will take place from September 7-10, in Milan, as well as virtually.
NORTH CHICAGO, Ill., July 29, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved RINVOQ® (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).*1
NORTH CHICAGO, Ill., July 27, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ®, 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]) for the treatment of adult patients with moderately to severely active Crohn's disease.4,11
NORTH CHICAGO, Ill., July 26, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the European Commission (EC) approved RINVOQ® (upadacitinib 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) for the treatment of adult patients 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.*
NORTH CHICAGO, Ill., June 27, 2022 /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® 15 mg, once daily) for the treatment of active non-radiographic axial spondyloarthritis (nr‑axSpA) in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).*
- Third approved indication for SKYRIZI (risankizumab-rzaa) is supported by safety and efficacy data from two induction and one maintenance clinical trials evaluating SKYRIZI in moderately to severely active Crohn's disease, ADVANCE, MOTIVATE and FORTIFY1-4
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