Monoclonal antibodies provide small benefits in Alzheimer’s disease
Jan 26, 2024
Harms include increased risks for amyloid-related imaging abnormalities (ARIA)-edema, ARIA-hemorrhage and symptomatic ARIA-edema.
Eligibility limited for anti-β amyloid mAbs in seniors with MCI
Aug 18, 2023
Few older adults with mild cognitive impairment or mild dementia were eligible for lecanemab or aducanumab after applying clinical trial criteria.
Medicare will cover new class of Alzheimer’s drugs if fully approved by FDA, with limits
Jun 02, 2023
Drug makers also will have to gather and keep data in a registry showing how the drugs are working in the real world.
FDA approves second drug for Alzheimer’s disease, despite safety concerns
Jan 06, 2023
The approval of lecanemab-irmb (Leqembi) comes after controversial approval in 2021 of aducanumab (Aduhelm), which met with criticism over concerns about that drug’s effectiveness, safety and pricing.
Congressional report slams FDA, drugmaker over approval of Alzheimer’s drug Aduhelm
Dec 29, 2022
The controversy over aducanumab (Aduhelm) stretches back to its June 2021 approval by the US Food and Drug Administration.
Study explores impact of FDA approval of aducanumab on trial participation
Dec 06, 2022
Individuals who were independently aware of the FDA decision demonstrated a reduced willingness to participate.