Lecanemab: Global criticism of final approval
10. July 2023
Lecanemab - Weltweite Kritik an endgültiger Zulassung - Musa Citak - TPS-Therapie

Lecanemab: Worldwide Criticism of Final Approval

FDA approves Alzheimer’s drug, but experts warn of dramatic consequences

On July 6, 2023, the anti-Alzheimer’s drug lecanemab marked a critical milestone in the United States that was both longed for by some and feared by others: The Food and Drug Administration (FDA), the U.S. regulatory agency for pharmaceuticals, finally granted the drug its approval, making it now available in the U.S. market. Known by the trade name “Leqembi,” the drug is intended for intravenous use under strict controls and is now officially being dispensed to Alzheimer’s patients. What remains to be seen is whether this controversial drug, whose therapeutic effect is considered modest and which carries significant risks, will also be given the green light in Europe.

Is lecanemab a glimmer of hope for patients:or are other interests in the foreground?

The debate about lecanemab has been intense and often controversial for months: some experts celebrate a “breakthrough” despite its nevertheless very limited successes and speak of a “hope for millions.” These opinions are often accompanied by media enthusiasm, which rarely brings the considerable side effects of the drug to the fore. However, numerous international scientists are following current developments with a critical or even alarmed eye. The question is whether Lecanemab is really a ray of hope – and if so, for whom? Is it really about the patients or rather about the stock market prices of the producing company?

To explain: according to studies, Lecanemab, like all other antibodies that have failed in studies before it, 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.

This is statistically significant, i.e. striking enough not to be considered a coincidence. However, it is not yet clear, as the Lecanemab researchers themselves admit, to what extent the patients are really likely to notice the difference in everyday life. Nor can it be deduced from the data how long a possible effect will last at all and how striking the side effects will be in practice.

Lecanemab: Fatal side effects, deaths, and alarmed researchers

That’s because lecanemab, which as mentioned has only been tested in early-onset Alzheimer’s dementia anyway, also has a strikingly large number of side effects and, more importantly, significant ones: For example, brain swelling occurred in 12.5 percent of the study probands, and 17 percent developed cerebral hemorrhages, which can be life-threatening. It is now also clear that several deaths are directly related to the drug.

For example, French neurologist Nicolas Villain, who was involved in the trials, reports that the study 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 don’t occur…” and refers to an investigation into one of the deaths attributed to the administration of lecanemab during the trials.

Against use of lecanemab: Scientists:inside launch campaigns against approval

Experts worldwide are running up a storm against the approval, and many scientist:in also warn against relying solely on the amyloid hypothesis.

For example, American neurologist Prof. Alberto Espay, professor of neurology at the University of Cincinnati, Ohio, USA, has called on colleagues worldwide to protest the FDA approval.

In the petition, which has already been signed by several hundred colleagues, he summarizes his reasons as succinctly as he does clearly. Among other things, he writes: “Lecanemab is ineffective and potentially so harmful that its use and cost cannot be justified. In addition to the known side effects, the size of the brains of those treated with lecanemab also 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 annual cost: $26,500, with $7,000.00 to be paid privately in any case

Add to that the horrendous cost: the drug’s price 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 there, burdening patients and their families with about $7,000 in co-payments per year, with no noticeable improvement or even worsening. In addition, there are the costs of necessary tests, especially imaging, and medical care.

What is the status of lecanemab in Europe or Germany?

In Europe, the drug is currently under review at the European Medicines Agency (EMA) in Amsterdam. The agency is expected to comment by the end of this year or early 2024, but declined to comment at this time.

In the event that lecanemab – again, by the way, contrary to the opinion of European experts – were also approved in Europe, only a fraction of people suffering from Alzheimer’s dementia would be eligible for treatment with lecanemab infusions anyway. Also how much the preparation in Germany for the Patient:innen would cost and where the Patient:innen should or could be treated at all, is not yet certain.

Apotheken-Umschau: Only 20,000 German Patient:in could be treated at all with Lecanemab

In GP practices, the Apotheken Umschau already wrote in its April issue, lecanemab could not be dispensed at all in our country. The treatment is time and care-intensive, since the drug must be administered intravenously every 14 days and the Patient:in must be monitored regularly in the MRT. And because the patient:s must meet strict criteria – the disease may only be in its early stages, with no symptoms already apparent, and many other co-diseases must be ruled out – only about 20,000 of the approximately 1.1 million people suffering from the dementia form of Alzheimer’s would even be eligible for the therapy.

Therapy methods such as transcranial pulse stimulation (TPS) continue to score points instead

In conclusion, the legitimate question must be raised in this context as to why modern, well-researched, long since clinically proven safe and multiply effective brain stimulation methods such as transcranial pulse stimulation and also other neurostimulation methods have so far hardly been taken note of in the public discussion. In contrast to Lecanemab, such methods can and have been successfully applied for a long time and for some indications already scientifically recognized at numerous university clinics, hospitals and practices. TPS also has the advantage that patients can be treated on an outpatient basis and that the extremely rare, brief side effects are marginal and negligible. In more than 5,000 patients treated so far, no significant side effect has ever been observed – not even in the long-term course over several years.

It stands therefore in the sense of the concerning and their members, in addition, in the sense of our health and care system overloaded for a long time to hope that modern therapy forms on physical basis can finally extend the possibilities of the pharmacy and contribute to the fact that the Patient:innen can be helped in the here and today safely and effectively.



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