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.
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FDA Confirms Paragraph IV Patent Litigation for Upadacitinib Extended-release Tablets 15 mg
AbbVie has released long-term efficacy and safety data from three Phase III trials investigating Rinvoq (upadacitinib) in moderate-to-severe atopic dermatitis.
NORTH CHICAGO, Ill., Oct. 11, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new data analyses from the Measure Up 1, Measure Up 2 and AD Up Phase 3 studies that further demonstrated the long-term efficacy and safety profile of RINVOQ® (upadacitinib) among adults and adolescents 12 years and older with moderate to severe atopic dermatitis through 140 weeks. Study results will be orally presented on Wednesday, October 11, at the 32nd European Academy of Dermatology and Venereology (EADV) Congress in Berlin.