On eve of Alzheimer’s drug decision, Congress critiques FDA for Aduhelm review failures
By
Alicia Lasek
Jan 03, 2023
An “atypical review process and corporate greed” factored into the FDA’s approval of Alzheimer’s drug Aduhelm in 2021, congressional investigators say. They recommend sticking to protocol...
Depression drug eases Alzheimer’s agitation; new death in lecanemab trial raises concerns
By
Alicia Lasek
Nov 30, 2022
Two drugs in late-stage clinical trials are making news, one as a potential treatment for agitation, and the other for evidence of bleeding risk.
First appropriate use guidance published for Alzheimer’s drug Aduhelm
By
Alicia Lasek
Jul 28, 2021
The new guidelines cover how to choose appropriate patients, safely scale up to a full dose, monitor side effects and assess effectiveness. The authors also address when to stop therapy and what patients...
U.S. lawmakers ramp up scrutiny of FDA following agency’s approval of controversial Alzheimer’s drug
By
Alicia Lasek
Sep 07, 2021
The FDA is being asked to help explain how Aduhelm (aducanumab) met accelerated approval criteria when so many experts — including internal advisers — have flagged insufficient safety and efficacy...
Eli Lilly aims for dementia drug candidate’s approval in 2022; wants to ‘prioritize access’
By
Alicia Lasek
Aug 04, 2021
The Alzheimer’s disease-modifying drug donanemab is on track to be considered for full FDA approval by 2022, its developer said.
Report: Monoclonal antibodies for dementia lack clear benefits, show risks
By
Kristen Fischer
Jan 23, 2024
Even though amyloid-reducing monoclonal antibodies (MABs) are on the market and some research shows they may treat Alzheimer’s disease and dementia, a new research review found there aren’t clear benefits...
Alzheimer’s drug donanemab finds late-stage trial success, safety concerns
By
Alicia Lasek
May 04, 2023
The experimental drug donanemab appears to halt the progression of Alzheimer’s disease and slow certain measures of clinical decline, new trial data show.
Patient advocates decry CMS decision on Alzheimer’s drug coverage
By
Alicia Lasek
Feb 24, 2023
The Alzheimer’s Association and others have strongly criticized a decision by CMS to stand by its highly restrictive coverage for new dementia drugs.