AbbVie (ABBV) Reports First-Quarter 2021 Financial Results streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
Upadacitinib meets all endpoints in Phase III ulcerative colitis trial
3
In the trial, 74 percent of participants responded to upadacitinib and 33 percent of patients achieved clinical remission.
According to AbbVie, upadacitinib (RINVOQ™) met all its primary endpoint of clinical remission and all ranked secondary endpoints in the Phase III induction study, U-ACCOMPLISH. In the trial, a third of ulcerative colitis patients receiving upadacitinib achieved clinical remission (per Adapted Mayo Score) at week eight, compared to four percent of patients receiving placebo.
U-ACCOMPLISH (NCT03653026) is a Phase III multi-centre, randomised, double-blind, placebo-controlled induction study to evaluate the efficacy and safety of upadacitinib 45mg taken once daily compared to placebo in adult subjects with moderate to severe ulcerative colitis. U-ACCOMPLISH is the second Phase III induction study to evaluate the safety and efficacy of upadacitinib in this indication.
Second Phase 3 Induction Study Confirms Upadacitinib (RINVOQ™) Improved Clinical, Endoscopic and Histologic Outcomes in Ulcerative Colitis Patients
- 33 percent of patients achieved the primary endpoint of clinical remission (per Adapted Mayo Score) compared to 4 percent of patients treated with placebo at week 8 (p 0.001)[1]
- All ranked secondary endpoints were met[1]
- These results reaffirm findings from the first Phase 3 induction study, U-ACHIEVE[1,2]
- Safety results were consistent with the previous Phase 3 induction study and the known profile of upadacitinib, with no new safety risks observed[1-6]
- Upadacitinib, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as an oral therapy for moderate to severe ulcerative colitis and several other immune-mediated diseases[1,7-14]
Second Phase 3 Induction Study Confirms Upadacitinib ) Improved Clinical, Endoscopic and Histologic Outcomes in Ulcerative Colitis Patients investingnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from investingnews.com Daily Mail and Mail on Sunday newspapers.
- Reports Full-Year Diluted EPS of $2.72 on a GAAP Basis; Adjusted Diluted EPS of $10.56
- Delivers Full-Year Net Revenues of $45.804 Billion on a GAAP Basis, an Increase of 37.7 Percent on a Reported Basis; Adjusted Net Revenues Were $45.784 Billion
- Full-Year Global Net Revenues from the Immunology Portfolio Were $22.153 Billion, an Increase of 13.2 Percent on a Reported Basis, or 13.4 Percent on an Operational Basis; U.S. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent; Internationally, Humira Net Revenues Were $3.720 Billion, a Decrease of 13.6 Percent on a Reported Basis, or 12.5 Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million