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...

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Veröffentlicht in:	Nature reviews. Neurology 2021-03, Vol.17 (3), p.129-130
Hauptverfasser:	Fillit, Howard, Green, Allan
Format:	Artikel
Sprache:	eng
Schlagworte:	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
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Zusammenfassung:	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.
ISSN:	1759-4758 1759-4766
DOI:	10.1038/s41582-020-00454-9