Posts Tagged ‘amyloid’
Should doctors prescribe lecanemab (Leqembi) to women? The answer, given available evidence, is probably No
Data from the CLARITY trial earlier this year was supposed to be the crowning glory of the amyloid hypothesis, vindication for proponents of this long-held but much-maligned theory of Alzheimer’s disease. Yet the results left many feeling underwhelmed, and even the study authors noncommittal. The CLARITY trial has many admirable features. It recruited close to…
Read MoreCMS: anti-amyloid drug Leqembi (lecanemab) doesn’t meet the “reasonable and necessary” standard required for wider Medicare coverage
CMS Sticks to Sharply Limited Coverage of New Alzheimer’s Drug, Leqembi (Managed Healthcare Executive): For now, CMS (Note: Centers for Medicare & Medicaid Services) is sticking to the coverage decision it made for Aduhelm (aducanumab) and applying it Leqembi (lecanemab). The decision limits Medicare coverage of the two Alzheimer disease’s drugs to Medicare beneficiaries who…
Read MoreCan the controversial FDA approval of Aduhelm backfire and delay the discovery of actual Alzheimer’s treatments? (Yes, it can)
The U.S. Food and Drug Administration (FDA) recently approved aducanumab, the first treatment that aims to slow the progression of Alzheimer’s disease. But approval of the drug has provoked mixed reactions from the scientific community. Alzheimer’s disease is characterized by progressive memory loss, spatial disorientation and many other cognitive and behavioural disorders that ultimately lead…
Read MoreFirst, do no harm? Six reasons to approach anti-amyloid drug Aduhelm cautiously, if at all
6 ways the FDA’s approval of Aduhelm does more harm than good (STAT News): Like many people, I was shocked when the Food and Drug Administration ignored the advice of its neurological drugs advisory panel and broadly approved Biogen’s new drug, Aduhelm, even for populations never included in the clinical trials to assess the drug.
Read MoreGrowing backlash against the FDA approval of unproven Alzheimer’s treatment Aduhelm, by Biogen
ICER Issues Statement on the FDA’s Approval of Aducanumab for Alzheimer’s Disease (Institute for Clinical and Economic Review): The Institute for Clinical and Economic Review (ICER) believes that the FDA, in approving aducanumab (Aduhelm™, Biogen) for the treatment of Alzheimer’s disease, has failed in its responsibility to protect patients and families from unproven treatments with…
Read MoreQuestionable “Alzheimer’s blood test” goes on sale prior to FDA approval
First blood test to help diagnose Alzheimer’s goes on sale (NBC News): A company has started selling the first blood test to help diagnose Alzheimer’s disease, a leap for the field that could make it much easier for people to learn whether they have dementia. It also raises concern about the accuracy and impact of such…
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