NORTH CHICAGO, Ill., July 12, 2024 /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®; 15 mg, once daily) for the treatment of adult patients with giant cell arteritis (GCA).
NORTH CHICAGO, Ill., June 4, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that RINVOQ® (upadacitinib) is indicated in the U.S. for the treatment of pediatric patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) as well as psoriatic arthritis (PsA), provided they have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Additionally, a new weight-based oral solution, RINVOQ® LQ (upadacitinib), is now available as an option for these pediatric populations.1
J&J acquires experimental skin disorder drug for $1.25 billion
NORTH CHICAGO, Ill., April 25, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from LEVEL UP, an open-label, efficacy assessor-blinded head-to-head Phase 3b/4 study that evaluated the efficacy and safety of upadacitinib (RINVOQ®, 15 mg once daily starting dose and dose-adjusted based on clinical response) versus dupilumab (DUPIXENT®, per its labeled dose) in adults and adolescents (?12 years of age) with moderate-to-severe atopic dermatitis (AD) who had an inadequate response to systemic therapy or when use of those therapies was inadvisable.
AbbVie announced positive top-line results from Select-GCA, a Phase 3, multicenter, randomized, double-blind, placebo-controlled study, showing upadacitinib in combination with a 26-week steroid taper regimen achieved its primary endpoint of sustained remissiona from week 12 through week 52 in adults with giant cell arteritis (GCA).
NORTH CHICAGO, Ill., April 18, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive top-line results from SELECT-GCA, a Phase 3, multicenter, randomized, double-blind, placebo-controlled study, showing upadacitinib (RINVOQ®; 15 mg, once daily) in combination with a 26-week steroid taper regimen achieved its primary endpoint of sustained remissiona from week 12 through week 52 in adults with giant cell arteritis (GCA). In this study, 46 percent of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission compared to 29 percent of patients receiving placebo in combination with a 52-week steroid taper regimen (p=0.0019).1
Less than a year ago, AbbVie's star immunology drug Rinvoq picked up its seventh FDA approval when the agency endorsed it in Crohn's disease. After a new positive pivotal trial, the drug could be bound for another label expansion.
AbbVie raises 2027 sales forecast for new immunology drugs to $27 billion
Looking to protect its lucrative immunology drug Rinvoq, AbbVie is suing a clutch of generic drug makers that are attempting to market copycat versions of the blockbuster.
FDA Confirms Paragraph IV Patent Litigation for Upadacitinib Extended-release Tablets 45 mg