Alzheimer’s drug lecanemab finally approved in the U.S.A.
Scientists:inside warn of false hopes and high risks
Last week, on July 06, 2023, the time had come: in the USA, the anti-body lecanemab was finally approved by the FDA and can be marketed there. Under the trade name “Leqembi”, the drug, which must be administered intravenously and under strict conditions, will now be officially distributed to Alzheimer’s patients. Whether the controversial drug, whose efficacy is classified as rather marginal and carries high risks, will also be approved in Europe is currently still questionable.
“Milestone in Alzheimer’s research” or casting out the devil with the Beelzebub after all?
For months now, huge discussions have been raging about the Lecanemab case: while some experts are jubilant about the nevertheless modest success and speak of a “breakthrough” and “hope for millions” – flanked by a corresponding media hype that usually only mentions the massive side effects of the drug in passing – many international scientists and European researchers are observing the current development critically or even appalled. The question arises: For whom is Lecanemab really a hope – for the patients or for the share prices of the manufacturer?
As a reminder: according to studies, Lecanemab, like all other antibodies that have previously failed in studies, is supposed to reduce the amyloid load, i.e. the protein deposits between the nerve cells – by 27 percent in Alzheimer’s patients in the early stages. However, according to French neurologist Nicolas Villain, who was involved in the studies, the results are statistically significant, but have little clinical significance. In a recent tweet, he shares his fears, “…Let’s just hope for the sake of the patients treated that numerous cases like this do not occur…” and refers to an investigation(1) on one of the deaths attributed to lecanemab administration during the trials.
Against Lecanemab Use: Scientists:launch petition
While researchers worldwide are up in arms against the approval in the United States and scientists:inside are also warning not to rely solely on the amyloid hypothesis (see related story: https://alzheimer-science.com/en/news/alzheimers-research/alzheimers-dependent-on-more-factors-than-just-amyloid ), American neurologists:inside have launched a petition.
Alberto Espay, professor of neurology at the University of Cincinnati, Ohio, USA, is calling on colleagues worldwide to protest FDA approval on change.org. We quote his petition text, which appeared three weeks before final approval, below:
“Lecanemab is neither safe nor effective for Alzheimer’s patients: Opposing FDA Approval.
Lecanemab has been portrayed as safe and effective, with a “slowing of cognitive decline” by 27 percent, giving patient:s a lot of hope. As the FDA prepares to decide whether to grant full approval for widespread use, available data suggest that lecanemab is ineffective and potentially harmful, making its use and cost unjustifiable.
Lecanemab does not improve patients’ condition.With or without lecanemab, the condition of clinical trial participants:in continued to worsen. On an 18-point scale, patients treated with lecanemab worsened by 1.21 points, whereas patients on placebo worsened by 1.66 points. This “improvement” (0.45 points) is not a change that the patients or their relatives could perceive (1-2 points). If 100 words represents perfect recall and we could remember 82 at the beginning of the study, we could remember 75 or 76 after 18 months with biweekly infusions, and 73 without, an absolute difference of only 2.5 percent.
Lecanemab may be harmful.Cerebral swelling occurred in 13 percent of treated patient:ing and small hemorrhages in 17 percent. The long-term consequences of these changes are unknown, but the size of the brains of those treated with lecanemab decreased significantly. A decrease in brain size is usually considered a sign of brain degeneration. In addition, three deaths were associated with lecanemab treatment.
Lecanemab is too expensive.The price of the drug is $26,500 per year, several times higher than the price of a conventional Alzheimer’s drug such as donepezil, whose benefits are modest but greater than those of lecanemab. Treating just one-tenth of the 6.7 million Americans believed to have Alzheimer’s would erode the Medicare budget and burden patients and their families with about $7,000 in co-payments per year, with no noticeable improvement or even worsening (Editor’s note: Added to this are costs for necessary tests, especially imaging, and for medical care).
We recommend that the use of lecanemab and its full approval by the FDA be stopped.”
The petition has already been signed by several hundred scientists:inside the United States, Australia and Europe.
It can be found at the following link:
1Source on the death cited by Nicolas Villain:
https://www.medrxiv.org/content/10.1101/2023.04.26.23289061v1
