2023-07-30 03:10:06
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Pharmaceutical companies also submit the application for lecanemab in the EU. A new biomarker could facilitate early detection of Alzheimer’s in the future.
Frankfurt – He has never been so optimistic “about our potential to change the way we treat and diagnose patients,” writes Howard Fillit, co-founder and scientific director of the US Alzheimer’s Drug Discovery Foundation, in one Report for the medical magazine “Stat”. The reason for the positive assessment of the doctor with more than 40 years of experience as a practicing geriatrician is the final approval of the Alzheimer’s drug “Leqembi” by the US Food and Drug Administration (FDA) at the beginning of July; the drug had already received a provisional approval in January.
In the United States, “Leqembi” can now be used in patients with early-stage Alzheimer’s disease. According to the German medical portal DocCheck, a treatment costs almost 26,000 dollars a year. In the EU, the manufacturers, the American biotechnology group Biogen and the Japanese pharmaceutical company Eisai, have meanwhile also submitted an application for approval.
Active substance lecanemab against Alzheimer’s
“Leqembi” contains the active substance lecanemab, an antibody that targets the protein amyloid-beta (also known as beta-amyloid, but both mean the same thing). In Alzheimer’s, it forms clumps in the brain that lead to deposits there – a process that is often underway for 20 years or more before the first cognitive impairments appear.
Espresso for Alzheimer’s?
In laboratory tests, components of the coffee beans act against typical processes of neurodegenerative diseases such as Alzheimer’s and Parkinson’s.
Amyloid beta is not the only protein involved in the development of Alzheimer’s, another key driver is the tau protein, which forms into fibrous fibrils – and it can be assumed that other mechanisms are also at work. Most of the Alzheimer’s drugs currently in development target amyloid beta, although quite a few have already failed in clinical trials. Howard Fillit describes Leqembi in his article as a “breakthrough” in this area.
Antibodies must be used at a very early stage of Alzheimer’s
However, the antibody, which is given intravenously every two weeks, has to be used at a very early stage, when mental damage is still minor. Only then is there a chance of slowing down the progression of the disease.
In the USA, where, in addition to lecanemab, there is another amyloid antibody on the market – albeit one that is controversial among experts – with aducanumab, the next drug from this group of drugs could soon be approved: Donanemab, manufactured by the US pharmaceutical company Eli Lilly, is also said to be in clinical trials and slowed cognitive decline by 35 percent.
According to the medical journal, this antibody has the advantage that infusions are only required every four weeks. However, due to their mode of action, both donanemab and lecanemab can also have serious side effects, because the rapid removal of the clumped proteins by the immune system can lead to edema in the brain and bleeding. What both drugs have in common is that they have to be given early. If the typical problems with memory and orientation are already clearly evident, the two antibodies can no longer slow down the course of the disease.
In Alzheimer’s, tau proteins (red threads with yellow dots) clump together to form fibrils and thus also change the structure of larger protein complexes. © Imago
It is important to diagnose Alzheimer’s before the first symptoms appear
It is therefore all the more important to diagnose Alzheimer’s early and preferably before the first symptoms appear. In addition, although the disease is by far the most common type of dementia, it is by no means the only one – and the antibodies do not work in other forms.
That is why research is being carried out just as intensively as on drugs, on methods that enable reliable and early diagnosis. The current gold standard is positron emission tomography (PET), an imaging technique used in nuclear medicine to look for amyloid or tau in the brain in the case of Alzheimer’s. However, this procedure is complex and expensive and is not recommended as routine diagnostics in the dementia guideline due to the low availability of devices. A blood test from C2N Diagnostics, which is intended to detect amyloid beta in the blood, is still relatively new; it received approval in both the USA and the EU two years ago.
Another biomarker that has not yet been approved is intended to detect deposits of the tau protein in the cerebrospinal fluid. An international research team led by neurologist Randall Bateman from Washington University St. Louis (USA) published data from a study with 650 participants in the journal “Nature Medicine” in mid-July. The authors propose using the marker called MTBR-tau243 not only to diagnose Alzheimer’s, but also to check the effects of drug therapy on tau proteins during ongoing treatment. (palm)
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