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The controversy surrounding the FDA approval of aducanumab for Alzheimer's disease treatment.
Current ‑approved treatments for fall into two broad groups: long-standing symptom‑relief drugs (cholinesterase inhibitors and memantine) and newer disease‑modifying anti‑amyloid monoclonal antibodies...
Three monoclonal antibody treatments that target amyloid-beta have been approved by U.S. regulators in recent years: aducanumab (Aduhelm) in 2021, lecanemab (Leqembi) in 2023 with updated maintenance ...
The FDA reviews Alzheimer’s drugs through either the traditional approval pathway—requiring substantial evidence of clinical benefit from Phase 3 randomized trials—or the Accelerated Approval pathway,...
Randomized, double‑blind trials of the newest FDA‑approved Alzheimer’s drugs—principally the anti‑amyloid monoclonal antibodies lecanemab (Leqembi) and donanemab (Kisunla)—have demonstrated statistica...
The FDA’s accelerated approval pathway lets Alzheimer’s drugs reach patients earlier by allowing approval on surrogate endpoints “reasonably likely” to predict benefit, with mandatory post‑marketing (...
Two families of peer‑reviewed, routinely cited treatments exist today: symptomatic agents (cholinesterase inhibitors and memantine) that modestly improve cognition or behavior, and more recently devel...
The FDA currently recognizes two classes of Alzheimer’s treatments: disease-targeted, anti-amyloid immunotherapies that have been shown to reduce brain amyloid and modestly slow cognitive decline in e...