2024-09-26 20:27:10
The news these days highlight the “progress” of the treatment Alzheimer’s disease. And studios are focusing on the decline beta-amyloid plaques in the brain, a a major feature of Alzheimer’s to create medicines. They are also working on raising the bar of their creations.
Not to mention, the media said exactly of those Leqembi drugwho provider, the pharmacist Jesse GmbHis trying to “sneak” it into the market by any means possible. Already last July European Medicines Agency (EMA) told him NO, that it is not approved for sale.
Well, the active ingredient of Leqembi, the lecanemabis a monoclonal antibody (a type of protein) that binds to a substance called beta amyloid, which forms plaques in the brains of people with Alzheimer’s disease. By binding to amyloid beta, the drug reduces amyloid plaques in the brain and thus is expected to cause the disease to worsen.
Why didn’t EMA authorize Leqembi?
Well, simple: The observed effect of Leqembi in delaying cognitive decline does not counteract the risk of special impact of the event associated with medicine. The most important security problem with Leqembi is the frequent occurrence of amyloid-related abnormal imaging (Aβ), a side effect seen on brain imaging involved swelling and possible bleeding in the brain.
Some patients have serious events, too large blood vessels in the brain requiring hospitalization.
Also, there is another technical issue: The risk of such bleeding is more pronounced in people who have a certain form of the protein gene. apolipoprotein E is called ApoE4. People with two copies of the gene ApoE4 is known to be at risk of developing Alzheimer’s disease and is therefore “possible eligible for treatment with Leqembi“, according to the Agency.
Overall, the EMA noted that the benefits of the treatment were not large enough to outweigh the measure risks associated with Leqembi. Therefore, it is recommended reject the order sales in the EU.
Leqembi is baked
Recently, the the effectiveness of anti-Alzheimer drugs that destabilize amyloid plaques is in question since it does not seem that these are the cause of the disease. How Nature publishes:
“Come on repeated failures of clinical trials “Targeting Aβ has cast much doubt on the amyloid cascade hypothesis and whether Alzheimer’s drug development has followed the right path.”
However, they comment in this scientific journal, the recent successes of trials targeting Aβ have removed these doubts. “In this review – these researchers continue – we discuss the evolution of the amyloid cascade hypothesis over the past 30 years and summarize its application in Diagnosis and treatment of Alzheimer’s disease. “In particular, we extensively discuss the pitfalls, promises, and important unanswered questions regarding current anti-Aβ therapy.”
End: Since Aβ aggregates act as a specific biomarker for Alzheimer’s, they are believed to be a promising target for modifying the course of the disease. But most drug trials targeting Aβ have fail.
And of course, This group It will not decrease.
Conflicts with Leqembi
Last summer’s decision by the EMA fell like a bucket of cold water on the benefits of Jessewhich is left without a large European Alzheimer’s market, very juicy since drug prices in the United States $27,500 per year…
Paradoxically, in North American countries, the Food and Drug Administration The US Food and Drug Administration (FDA) approved lecanemab in 2023. A The manufacturer’s test showed a 27% reduction in cognitive decline for 18 months versus placebo, which equates to a reduction in disease progression at six months.
It was later approved in Japan, China, South Korea and Israel. Then it will come reaction from EMA. And more contradictions. On August 22, the UK Medicines and Healthcare Products Regulatory Agency gave it the green light used in people with Alzheimer’s disease early. But at the same time, the National Institute for Health and Care Excellence (NICE) decided that the drug was not profitable for the country, due to its high cost.
In this way, we focus on a drug that is widely advertised, but is not legal in the EU because of it possible serious brain damageprecisely in the population group whose disease is related to their brain. The efficiency of Leqembi is in question, and its price scares the city administrations.
And be careful, it must be very bad for a powerful pharmaceutical company not to sneak one of its new treatments into the EMA. As the doctor pointed out Abel Novoaformer president of No thanks (health professionals for ethics), who criticize the decision of the highest European on drugs, are those who have. conflict of interest with the pharmaceutical company that promotes it:
Since the drug can’t be sold and even if it can, it can NOT be advertised directly, what the laboratory does is go to the special media to mess it up.
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