Alzheimer’s disease is a devastating form of dementia affecting millions worldwide. A new drug, called aducanumab, has been approved by the FDA for treating Alzheimer’s. The drug works by clearing the toxic amyloid plaques that build up in the brain and cause memory loss. Many reports appeared last year disputing the amyloid hypothesis. The success of similar drugs in the past has been dismal.

#health #Alzheimers #aducanumab

https://www.womansworld.com/posts/health/alzheimers-cure

The #FDA is the lapdog of #BigPharma

https://newstarget.com/2023-01-17-new-fda-miracle-drug-accelerates-arthritis-alzheimers.html

#aducanumab #Aduhelm #scam

The #FDA is the lapdog of #BigPharma

https://www.naturalnews.com/2023-01-17-new-fda-miracle-drug-accelerates-arthritis-alzheimers.html

#aducanumab #Aduhelm #scam

FDA approves #lecenemab via accelerated mechanism (same as #aducanumab):

https://www.statnews.com/2023/01/06/fda-approves-alzheimers-drug-leqembi-eisai/

CMS will still need to decide about Medicare coverage.

Eisai expected to seek full FDA approval based on additional cognitive outcomes data.

#dementia #alzheimers

"The 18-month investigation, initiated by two congressional committees after the F.D.A. approved the drug, also strongly criticized Biogen, Aduhelm’s manufacturer. Internal documents showed the company set “an unjustifiably high price” of $56,000 a year for Aduhelm because it wanted a history-making “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found."

#Aduhelm #MonoclonalAntibody #Alzheimer #AlzheimersDisease #Aducanumab

https://www.nytimes.com/2022/12/29/health/alzheimers-drug-aduhelm-biogen.html?action=click&module=Well&pgtype=Homepage&section=Health

Update on #aducanumab fiasco:

Congressional investigation into regulatory capture of the FDA is damning.

https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Final%20Aduhelm%20Report_12.29.22.pdf

TL;DR:

#Lecanemab, like #aducanumab, only slightly effective in delaying cognitive decline in people with #Alzheimers disease.

Seems to be better tolerated than aducanumab.

Black people with Alzheimer's disease underrepresented in a clinical trial, yet again.

TL;DR:

#Lecanemab, like #aducanumab, only slightly effective on delaying cognitive decline in people with #Alzheimers disease.

Seems to be better tolerated than aducanumab.

Black people with Alzheimer's disease underrepresented in a clinical trial, yet again.

As with #aducanumab trials EMERGE/ENGAGE, Black people were underrepresented:

20/859 lecanemab (2.3%)
24/875 placebo (2.7%)

The effect on applying the results to clinical practice are immediately apparent in the attached graph:

Whereas cognitive effects of #lecanemab were statistically significant in White study participants, cognitive effects were NOT statistically significant in Black study participants.

The study was underpowered to demonstrate effect in Black people with #Alzheimers.

Tolerability of #lecanemab seems to be better than that of #aducanumab (though this wasn't a head-to-head comparison, so we can't be sure):

- infusion-related reactions: 26.4% lecanemab vs 7.4% placebo, usually with first infusion and usually mild
- ARIA-H: 17.3% vs 9.0%
- ARIA-E: 12.6% vs 1.7%

There were 6 deaths (0.7%) reported with lecanemab vs 7 (0.8%) with placebo.

Note, however, recent reports of two deaths in people receiving lecanemab:

https://www.science.org/content/article/second-death-linked-potential-antibody-treatment-alzheimer-s-disease

As with #aducanumab, #lecanemab demonstrated remarkable clearing of #amyloid.

This further calls into doubt the relationship between amyloid reduction and cognitive improvement.

The first peer-reviewed results of #lecanemab for #Alzheimers disease are now out:

https://www.nejm.org/doi/full/10.1056/NEJMoa2212948

Bottom line:
- very modest cognitive benefit: 0.45 difference between lecanemab & placebo on an 18-point scale (CDR-SB) over 18 months
- fair amount of side effects, including ARIA-H, ARIA-E & infusion reactions (though appear to be fewer than with #aducanumab).