原始来源记录
决策级FDA 说明书更新
AbbVie：FDA批准Rinvoq标签更新，适用于UC和CD
FDA批准了一项补充新药申请，更新了Rinvoq的适应症声明，允许在UC和CD患者中使用TNF阻滞剂之前使用，前提是TNF治疗在临床上不适宜且患者已接受至少一种已批准的系统治疗。这扩大了符合条件的患者群体，并取消了某些患者先前必须先使用TNF阻滞剂的要求。
关键事实
来源摘录
EX-99.1 2 abbv-20250930xexhibit991.htm EX-99.1 Document PRESS RELEASE AbbVie Reports Third-Quarter 2025 Financial Results • Reports Third-Quarter Diluted EPS of $0.10 on a GAAP Basis, a Decrease of 88.6 Percent; Adjusted Diluted EPS of $1.86, a Decrease of 38.0 Percent; These Results Include an Unfavorable Impact of $1.50 Per Share Related to Acquired IPR&D and Milestones Expense • Delivers Third-Quarter Net Revenues of $15.776 Billion, an Increase of 9.1 Percent on a Reported Basis or 8.4 Percent on an Operational Basis • Third-Quarter Global Net Revenues from the Immunology Portfolio Were $7.885 Billion, an Increase of 11.9 Percent on a Reported Basis, or 11.2 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $4.708 Billion; Global Rinvoq Net Revenues Were $2.184 Bi