{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T11:53:03Z","timestamp":1792842783751,"version":"4.5.0"},"reference-count":11,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2021,9,1]],"date-time":"2021-09-01T00:00:00Z","timestamp":1630454400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2021,9,1]],"date-time":"2021-09-01T00:00:00Z","timestamp":1630454400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2021,9,1]],"date-time":"2021-09-01T00:00:00Z","timestamp":1630454400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2021,9,1]],"date-time":"2021-09-01T00:00:00Z","timestamp":1630454400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2021,9,1]],"date-time":"2021-09-01T00:00:00Z","timestamp":1630454400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2021,9,1]],"date-time":"2021-09-01T00:00:00Z","timestamp":1630454400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2021,9,1]],"date-time":"2021-09-01T00:00:00Z","timestamp":1630454400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"funder":[{"DOI":"10.13039\/501100013120","name":"European Medicines Agency","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100013120","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Pharmacological Research"],"published-print":{"date-parts":[[2021,9]]},"DOI":"10.1016\/j.phrs.2021.105754","type":"journal-article","created":{"date-parts":[[2021,7,2]],"date-time":"2021-07-02T04:05:21Z","timestamp":1625198721000},"page":"105754","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":61,"special_numbering":"C","title":["Aducanumab for Alzheimer\u2019s disease: A regulatory perspective"],"prefix":"10.1016","volume":"171","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3433-9232","authenticated-orcid":false,"given":"Robert","family":"Nistic\u00f2","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John Joseph","family":"Borg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.phrs.2021.105754_bib1","doi-asserted-by":"crossref","first-page":"184","DOI":"10.1126\/science.1566067","article-title":"Alzheimer\u2019s disease: the amyloid cascade hypothesis","volume":"256","author":"Hardy","year":"1992","journal-title":"Science"},{"key":"10.1016\/j.phrs.2021.105754_bib2","doi-asserted-by":"crossref","first-page":"331","DOI":"10.1016\/j.phrs.2018.02.014","article-title":"Alzheimer Precision Medicine Initiative (APMI). Precision pharmacology for Alzheimer\u2019s disease","volume":"130","author":"Hampel","year":"2018","journal-title":"Pharmacol. Res"},{"key":"10.1016\/j.phrs.2021.105754_bib3","doi-asserted-by":"crossref","first-page":"696","DOI":"10.1002\/alz.12213","article-title":"Failure to demonstrate efficacy of aducanumab: an analysis of the EMERGE and ENGAGE trials as reported by Biogen, December 2019","volume":"17","author":"Knopman","year":"2021","journal-title":"Alzheimers Dement."},{"key":"10.1016\/j.phrs.2021.105754_bib4","unstructured":"EMA\/CHMP\/708314\/2020, Committee for Medicinal Products for Human Use (CHMP) Minutes for the Meeting on 09\u201312 November 2020, 5 January 2021."},{"key":"10.1016\/j.phrs.2021.105754_bib5","unstructured":"EMA\/480969\/2015, Stakeholders and Communication Division EMA regulatory tools for early access to medicines. Conditional Marketing Authorisation and Accelerated Assessment Draft Revised Guidelines \u2013 Description of Tools and Overview of Changes, 24 July 2015."},{"key":"10.1016\/j.phrs.2021.105754_bib6","unstructured":"EMA\/647097\/2015, Committee for medicinal products for human use. Overview of Comments Received on \u2018Guideline on the Scientific Application and the Practical Arrangements Necessary to Implement Commission Regulation (EC) No 507\/2006 on the Conditional Marketing Authorisation for Medicinal Products for Human Use Falling within the Scope of Regulation (EC) No 726\/2004 (EMA\/CHMP\/509951\/2006, Rev.1), 25 February 2016."},{"key":"10.1016\/j.phrs.2021.105754_bib7","unstructured":"EMA\/PDCO\/CAT\/CMDh\/PRAC\/CHMP\/261500\/2015, Scientific Guidance on Post-authorisation Efficacy Studies, 12 October 2016."},{"key":"10.1016\/j.phrs.2021.105754_bib8","doi-asserted-by":"crossref","DOI":"10.1038\/s41591-021-01369-8","article-title":"A trial of gantenerumab or solanezumab in dominantly inherited Alzheimer\u2019s disease","author":"Salloway","year":"2021","journal-title":"Nat. Med."},{"key":"10.1016\/j.phrs.2021.105754_bib9","doi-asserted-by":"crossref","DOI":"10.1016\/j.eclinm.2021.100988","article-title":"High cerebrospinal amyloid-\u03b2 42 is associated with normal cognition in individuals with brain amyloidosis","author":"Sturchio","year":"2021","journal-title":"Eclinicalmedicine"},{"key":"10.1016\/j.phrs.2021.105754_bib10","doi-asserted-by":"crossref","first-page":"111","DOI":"10.1016\/S1474-4422(19)30480-6","article-title":"A resurrection of aducanumab for Alzheimer\u2019s disease","volume":"19","author":"Schneider","year":"2020","journal-title":"Lancet Neurol."},{"key":"10.1016\/j.phrs.2021.105754_bib11","doi-asserted-by":"crossref","first-page":"195","DOI":"10.1002\/cpt.1565","article-title":"Comparison of EMA and FDA decisions for new drug marketing applications 2014\u20132016: concordance, discordance, and why","volume":"107","author":"Kashoki","year":"2020","journal-title":"Clin. Pharmacol. Ther."}],"container-title":["Pharmacological Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1043661821003388?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1043661821003388?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T22:23:32Z","timestamp":1760912612000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1043661821003388"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,9]]},"references-count":11,"alternative-id":["S1043661821003388"],"URL":"https:\/\/doi.org\/10.1016\/j.phrs.2021.105754","relation":{},"ISSN":["1043-6618"],"issn-type":[{"value":"1043-6618","type":"print"}],"subject":[],"published":{"date-parts":[[2021,9]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Aducanumab for Alzheimer\u2019s disease: A regulatory perspective","name":"articletitle","label":"Article Title"},{"value":"Pharmacological Research","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.phrs.2021.105754","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2021 Elsevier Ltd. All rights reserved.","name":"copyright","label":"Copyright"}],"article-number":"105754"}}