1차 출처 기록
결정급FDA 승인
AbbVie: FDA, 미치료 CLL에 Venclexta + Acalabrutinib 승인
FDA가 미치료 CLL에 대한 최초의 all-oral fixed-duration regimen으로 Venclexta (venetoclax) plus acalabrutinib의 sNDA를 승인했습니다. 승인은 Phase 3 AMPLIFY 시험 데이터에 의해 뒷받침됩니다.
핵심 사실
출처 발췌
EX-99.1 2 abbv-20260331xexhibit991.htm EX-99.1 Document PRESS RELEASE AbbVie Reports First-Quarter 2026 Financial Results • Reports First-Quarter Diluted EPS of $0.39 on a GAAP Basis, a Decrease of 45.8 Percent; Adjusted Diluted EPS of $2.65, an Increase of 7.7 Percent; These Results Include an Unfavorable Impact of $0.41 Per Share Related to Acquired IPR&D and Milestones Expense • Delivers First-Quarter Net Revenues of $15.002 Billion, an Increase of 12.4 Percent on a Reported Basis or 10.3 Percent on an Operational Basis • First-Quarter Global Net Revenues from the Immunology Portfolio Were $7.290 Billion, an Increase of 16.4 Percent on a Reported Basis, or 14.3 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $4.483 Billion; Global Rinvoq Net Revenues Were $2.119