FDA一再打破常规，在“首个”阿兹海默病新药上市过程中……( 五 )

[8]Knopman DS, Jones DT, Greicius MD.Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE andENGAGE trials as reported by Biogen, December 2019[J]. Alzheimers Dement. 2021Apr;17(4):696-701. doi: 10.1002/alz.12213.

[9]Nevens F, Andreone P, Mazzella G, et al;POISE Study Group. A Placebo-Controlled Trial of Obeticholic Acid in PrimaryBiliary Cholangitis. N Engl J Med. 2016 Aug 18;375(7):631-43. doi:10.1056/NEJMoa1509840.

[10] Bhatt DL, Stone GW, Mahaffey KW, et al;CHAMPION PHOENIX Investigators. Effect of platelet inhibition with cangrelorduring PCI on ischemic events[J]. N Engl J Med. 2013 Apr 4;368(14):1303-13.doi: 10.1056/NEJMoa1300815.

[11]Haeberlein, S.B., von Hehn, C., Tian,Y., et al. Emerge and Engage topline results: Phase 3 studies of aducanumab inearly Alzheimer’s disease[J]. Alzheimer's Dement., 16: e047259. doi:10.1002/alz.047259

[12]Biogen Inc. EMERGE and ENGAGE ToplineResults: Two Phase 3 Studies to Evaluate Aducanumab in Patients With Early Alzheimer’sDisease[EB/OL].[2020-05-09] http://investors.biogen.com/static-files/8e58afa4-ba37-4250-9a78-2ecfb63b1dcb

【FDA一再打破常规，在“首个”阿兹海默病新药上市过程中……】[13]The U.S. Food and Drug Administration.FDA grants accelerated approval to new treatment for advanced soft tissuesarcoma[EB/OL].[2019-02-22] http://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-new-treatment-advanced-soft-tissue-sarcoma