Experts: More research needed before treating patients with controversial Alzheimer’s drug Aduhelm
By
Amy Novotney
Sep 13, 2021
The majority of patients with Alzheimer’s disease would not have been eligible to take part in the clinical trials of the new controversial Alzheimer’s drug aducanumab (Aduhelm), according...
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...
VA will not add Alzheimer’s drug Aduhelm to its formulary
By
Alicia Lasek
Aug 12, 2021
The Department of Veterans Affairs has chosen not to include aducanumab (Aduhelm) in its national list of covered drugs, citing risk of adverse events and lack of evidence of positive impact on cognition,...
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...
New Alzheimer’s drug Aduhelm has no clinical benefit, panel of medical experts concludes
By
Alicia Lasek
Jul 21, 2021
The drug does not improve upon the current standard of care for Alzheimer’s disease, say advisers to the Institute for Clinical and Economic Review, a drug pricing watchdog.
Slow buy-in: Only 3% of neurologists have written Aduhelm prescriptions so far
By
Alicia Lasek
Jul 15, 2021
Neurologists are very aware of Biogen’s newly approved Alzheimer’s drug, but few have prescribed it so far, a real-time study of the brand’s market launch has found.
CMS to weigh national Medicare coverage for Aduhelm, other Alzheimer’s drugs
By
Alicia Lasek
Jul 14, 2021
The agency is considering whether to establish a national coverage policy for monoclonal antibody drugs that treat Alzheimer’s disease, including the newly approved drug aducanumab (Aduhelm).
FDA calls for investigation into its approval of controversial Alzheimer’s drug
By
Alicia Lasek
Jul 12, 2021
The acting chief of the Food and Drug Administration has called for an investigation into the events leading up to the approval of Biogen’s brain plaque-clearing dementia drug aducanumab (Aduhelm).
FDA limits use of new dementia drug Aduhelm to mild cognitive impairment only
By
Alicia Lasek
Jul 09, 2021
The FDA’s new label restricts Aduhelm’s use to Alzheimer’s patients with mild cognitive impairment or mild dementia, drugmaker Biogen announced Thursday.
House committees to investigate new Alzheimer’s disease drug approval
Jul 01, 2021
FDA approved Aduhelm earlier this month, despite advisory committee’s conclusion that there was not enough evidence to support its effectiveness