Whitehouse P, Gandy S, Saini V, George DR, Larson EB, Alexander GC, Avorn J, Brownlee S, Camp C, Chertkow H, Fugh-Berman A, Howard R, Kesselheim AS, Langa KM, Perry G, Richard E, Schneider L - Journal of Alzheimer’s Disease
- Commentary & Opinion
- Regulation and Clinical Evidence
Summary:
An international group of clinicians, researchers, and dementia advocates unanimously recommended that the FDA withdraw its approval of aducanumab (Aduhelm) due to insufficient evidence of clinical efficacy, safety concerns, and cost considerations. The group supported filing a formal Citizen Petition calling for the reversal of the drug’s controversial June 2021 approval, citing significant problems with the approval process.
VIEW SOURCE
Recent Work from PORTAL
How Congress Can Fix Expert Advisory Committees
Daval CJR, Kesselheim AS - STAT
- Commentary & Opinion
- Regulation and Clinical Evidence
International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway
Mulsant SS, Kesselheim AS, Naci H - Journal of Cancer Policy
- Research Publications
- Price, Value, and Access
- Regulation and Clinical Evidence
Politics and the Patient Encounter, in Dire Times
Avorn J - MedPage Today
- Commentary & Opinion
- Regulation and Clinical Evidence
Program On Regulation, Therapeutics, And Law (PORTAL)
Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women's Hospital • Harvard Medical School
41 Avenue Louis Pasteur, Suite 0B17, Boston, MA 02115
©2026 Program On Regulation, Therapeutics, And Law (PORTAL). All rights reserved.