Aducanumab and the FDA — where are we now?
The amyloid antibody aducanumab is currently undergoing review by the FDA. The treatment would be the first disease-modifying drug to be approved for Alzheimer disease; however, a medical advisory committee recently convened by the FDA did not recommend approval, raising questions about whether the...
Gespeichert in:
| Veröffentlicht in: | Nature reviews. Neurology 2021-03, Vol.17 (3), p.129-130 |
|---|---|
| Hauptverfasser: | , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 130 |
|---|---|
| container_issue | 3 |
| container_start_page | 129 |
| container_title | Nature reviews. Neurology |
| container_volume | 17 |
| creator | Fillit, Howard Green, Allan |
| description | The amyloid antibody aducanumab is currently undergoing review by the FDA. The treatment would be the first disease-modifying drug to be approved for Alzheimer disease; however, a medical advisory committee recently convened by the FDA did not recommend approval, raising questions about whether the existing evidence of efficacy is sufficient. |
| doi_str_mv | 10.1038/s41582-020-00454-9 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_miscellaneous_2478036633</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A655717484</galeid><sourcerecordid>A655717484</sourcerecordid><originalsourceid>FETCH-LOGICAL-c539t-8ff4f2b0db4675d298a3aa2671fa83d1c73f2012c54dd5ff6c06773b1687ec33</originalsourceid><addsrcrecordid>eNp9kd1KHDEcxUOpVLv6Ar0oAwXxwrH5TuZKFnWtIPTG-5DJhzsyk9hkhqV3fQif0Ccx2_WjFpEQ8if5nUMOB4AvCB4hSOT3TBGTuIYY1hBSRuvmA9hBgjU1FZx_fJ6Z3Aafc76BkHOC0SewTQilGHK6Aw7ndjI6TINuKx1sNS5dtTidV_d_7qrV0iVX6bJXrgpxdbwLtrzus9t7PGfganF2dfKjvvx5fnEyv6wNI81YS--pxy20LeWCWdxITbTGXCCvJbHICOIxRNgwai3znhvIhSAt4lI4Q8gMHGxsb1P8Nbk8qqHLxvW9Di5OWWEqJCQlyxr99h96E6cUyucK1XDMUSPZC3Wte6e64OOYtFmbqjlnTCBBJS3U0RtUWdYNnYnB-a7cvxLs_yNYOt2Pyxz7aexiyK9BvAFNijkn59Vt6gadfisE1bpKtalSlSrV3ypVU0RfH6NN7eDss-SpuwKQDZDLU7h26SX7O7YP1sWkBA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2496261985</pqid></control><display><type>article</type><title>Aducanumab and the FDA — where are we now?</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Fillit, Howard ; Green, Allan</creator><creatorcontrib>Fillit, Howard ; Green, Allan</creatorcontrib><description>The amyloid antibody aducanumab is currently undergoing review by the FDA. The treatment would be the first disease-modifying drug to be approved for Alzheimer disease; however, a medical advisory committee recently convened by the FDA did not recommend approval, raising questions about whether the existing evidence of efficacy is sufficient.</description><identifier>ISSN: 1759-4758</identifier><identifier>EISSN: 1759-4766</identifier><identifier>DOI: 10.1038/s41582-020-00454-9</identifier><identifier>PMID: 33442064</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>631/378/1689/1283 ; 692/617/375/132/1283 ; Alzheimer Disease - drug therapy ; Alzheimer Disease - epidemiology ; Alzheimer's disease ; Analysis ; Antibodies, Monoclonal, Humanized - therapeutic use ; Comment ; Drug approval ; Drug Approval - methods ; Drug therapy ; Humans ; Medicine ; Medicine & Public Health ; Monoclonal antibodies ; Neurology ; Pharmaceutical industry ; Product development ; United States - epidemiology</subject><ispartof>Nature reviews. Neurology, 2021-03, Vol.17 (3), p.129-130</ispartof><rights>Springer Nature Limited 2021</rights><rights>COPYRIGHT 2021 Nature Publishing Group</rights><rights>Springer Nature Limited 2021.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c539t-8ff4f2b0db4675d298a3aa2671fa83d1c73f2012c54dd5ff6c06773b1687ec33</citedby><cites>FETCH-LOGICAL-c539t-8ff4f2b0db4675d298a3aa2671fa83d1c73f2012c54dd5ff6c06773b1687ec33</cites><orcidid>0000-0002-3509-6706</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1038/s41582-020-00454-9$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1038/s41582-020-00454-9$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33442064$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fillit, Howard</creatorcontrib><creatorcontrib>Green, Allan</creatorcontrib><title>Aducanumab and the FDA — where are we now?</title><title>Nature reviews. Neurology</title><addtitle>Nat Rev Neurol</addtitle><addtitle>Nat Rev Neurol</addtitle><description>The amyloid antibody aducanumab is currently undergoing review by the FDA. The treatment would be the first disease-modifying drug to be approved for Alzheimer disease; however, a medical advisory committee recently convened by the FDA did not recommend approval, raising questions about whether the existing evidence of efficacy is sufficient.</description><subject>631/378/1689/1283</subject><subject>692/617/375/132/1283</subject><subject>Alzheimer Disease - drug therapy</subject><subject>Alzheimer Disease - epidemiology</subject><subject>Alzheimer's disease</subject><subject>Analysis</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Comment</subject><subject>Drug approval</subject><subject>Drug Approval - methods</subject><subject>Drug therapy</subject><subject>Humans</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Monoclonal antibodies</subject><subject>Neurology</subject><subject>Pharmaceutical industry</subject><subject>Product development</subject><subject>United States - epidemiology</subject><issn>1759-4758</issn><issn>1759-4766</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kd1KHDEcxUOpVLv6Ar0oAwXxwrH5TuZKFnWtIPTG-5DJhzsyk9hkhqV3fQif0Ccx2_WjFpEQ8if5nUMOB4AvCB4hSOT3TBGTuIYY1hBSRuvmA9hBgjU1FZx_fJ6Z3Aafc76BkHOC0SewTQilGHK6Aw7ndjI6TINuKx1sNS5dtTidV_d_7qrV0iVX6bJXrgpxdbwLtrzus9t7PGfganF2dfKjvvx5fnEyv6wNI81YS--pxy20LeWCWdxITbTGXCCvJbHICOIxRNgwai3znhvIhSAt4lI4Q8gMHGxsb1P8Nbk8qqHLxvW9Di5OWWEqJCQlyxr99h96E6cUyucK1XDMUSPZC3Wte6e64OOYtFmbqjlnTCBBJS3U0RtUWdYNnYnB-a7cvxLs_yNYOt2Pyxz7aexiyK9BvAFNijkn59Vt6gadfisE1bpKtalSlSrV3ypVU0RfH6NN7eDss-SpuwKQDZDLU7h26SX7O7YP1sWkBA</recordid><startdate>20210301</startdate><enddate>20210301</enddate><creator>Fillit, Howard</creator><creator>Green, Allan</creator><general>Nature Publishing Group UK</general><general>Nature Publishing Group</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-3509-6706</orcidid></search><sort><creationdate>20210301</creationdate><title>Aducanumab and the FDA — where are we now?</title><author>Fillit, Howard ; Green, Allan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c539t-8ff4f2b0db4675d298a3aa2671fa83d1c73f2012c54dd5ff6c06773b1687ec33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>631/378/1689/1283</topic><topic>692/617/375/132/1283</topic><topic>Alzheimer Disease - drug therapy</topic><topic>Alzheimer Disease - epidemiology</topic><topic>Alzheimer's disease</topic><topic>Analysis</topic><topic>Antibodies, Monoclonal, Humanized - therapeutic use</topic><topic>Comment</topic><topic>Drug approval</topic><topic>Drug Approval - methods</topic><topic>Drug therapy</topic><topic>Humans</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Monoclonal antibodies</topic><topic>Neurology</topic><topic>Pharmaceutical industry</topic><topic>Product development</topic><topic>United States - epidemiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fillit, Howard</creatorcontrib><creatorcontrib>Green, Allan</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Nature reviews. Neurology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fillit, Howard</au><au>Green, Allan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Aducanumab and the FDA — where are we now?</atitle><jtitle>Nature reviews. Neurology</jtitle><stitle>Nat Rev Neurol</stitle><addtitle>Nat Rev Neurol</addtitle><date>2021-03-01</date><risdate>2021</risdate><volume>17</volume><issue>3</issue><spage>129</spage><epage>130</epage><pages>129-130</pages><issn>1759-4758</issn><eissn>1759-4766</eissn><abstract>The amyloid antibody aducanumab is currently undergoing review by the FDA. The treatment would be the first disease-modifying drug to be approved for Alzheimer disease; however, a medical advisory committee recently convened by the FDA did not recommend approval, raising questions about whether the existing evidence of efficacy is sufficient.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>33442064</pmid><doi>10.1038/s41582-020-00454-9</doi><tpages>2</tpages><orcidid>https://orcid.org/0000-0002-3509-6706</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1759-4758 |
| ispartof | Nature reviews. Neurology, 2021-03, Vol.17 (3), p.129-130 |
| issn | 1759-4758 1759-4766 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2478036633 |
| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | 631/378/1689/1283 692/617/375/132/1283 Alzheimer Disease - drug therapy Alzheimer Disease - epidemiology Alzheimer's disease Analysis Antibodies, Monoclonal, Humanized - therapeutic use Comment Drug approval Drug Approval - methods Drug therapy Humans Medicine Medicine & Public Health Monoclonal antibodies Neurology Pharmaceutical industry Product development United States - epidemiology |
| title | Aducanumab and the FDA — where are we now? |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-12T19%3A29%3A45IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_proqu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Aducanumab%20and%20the%20FDA%20%E2%80%94%20where%20are%20we%20now?&rft.jtitle=Nature%20reviews.%20Neurology&rft.au=Fillit,%20Howard&rft.date=2021-03-01&rft.volume=17&rft.issue=3&rft.spage=129&rft.epage=130&rft.pages=129-130&rft.issn=1759-4758&rft.eissn=1759-4766&rft_id=info:doi/10.1038/s41582-020-00454-9&rft_dat=%3Cgale_proqu%3EA655717484%3C/gale_proqu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2496261985&rft_id=info:pmid/33442064&rft_galeid=A655717484&rfr_iscdi=true |