Japanese drug raises hopes for treating Alzheimer's
Developed by the pharmaceutical company Eisai, it has been approved by the FDA in the US and will be available on the American market as early as this month. According to tests, it does not act on the symptoms of the disease, but on its causes by removing betamyloid deposits. Not all the scientific world is convinced, however, that focusing on this protein will produce effects. The crux of the matter is cost and coverage by health insurances.
Tokyo (AsiaNews/Agencies) - The road to defeating Alzheimer's is still a long one, but that is precisely why every small advance should be considered a major milestone. A few days ago, the US Food and Drug Administration (FDA) approved lecanemab, a drug that works against the neurodegenerative disease by slowing its progression.
Lecanemab, developed by Japanese pharmaceutical company Eisai jointly with its US partner Biogen, will be available in the US market as early as this month under the name Leqembi.
Haruo Naito, Eisai's CEO, said the company aims to file for approval in Japan, Europe, and China as soon as possible. Ideally, the hope is that the product will be approved by 2023.
According to clinical trial results presented last September by the manufacturers, the treatment slows the progress of the disease by 27%. This figure was obtained based on the Clinical Dementia Rating, a numerical scale used to quantify the severity of disease-induced impairment in areas such as memory, orientation, judgement, problem-solving and self-care.
The study conducted during phase 3 on the 1800 patients who consented to the experimental treatment showed that - if administered during the early stages of the disease - lecanemab can slow down the decline in cognitive functions.
The FDA approving the drug said it was an 'important step forward in the fight to cure Alzheimer's disease'. Unlike other available options, lecanemab does not act on the symptoms of the disease but on the causes themselves.
In fact, the principle behind the treatment developed by Eisai and Biogen is to remove deposits of the protein known as betamyloid, the accumulation of which in brain tissue is said to be linked to the progress of the disease.
Not everyone, however, is convinced of the solution. According to Dr. Kristian Steen Frederiksen, director of the clinical trials unit at the University of Copenhagen, told Reuters, Alzheimer's is an extremely complex disease and 'betamyloid is unlikely to be the only factor at play'. For this reason, 'focusing only on this target is unlikely to produce large-scale effects'.
Lecanemab is not the first therapy developed by Eisai and Biogen. In December 2021, the two pharmaceutical companies had presented a similar product that was marketed in the US under the name Aduhelm.
However, scientific disagreements over its efficacy and the decision by the federal health insurance company not to cover the cost of the drug (whose annual price was ,000) decreed Aduhelm's failure in the US, while it was not even approved in Japan.
Naito hopes that things will now be different and that the US authorities will this time decide to include the treatment in health insurance. To make the new drug more affordable, the price of Leqembi has been set at around ,500 per year.
In Japan, on the other hand, the approval process is expected to begin next March and Eisai has agreed to discuss the cost with the Japanese authorities in order to allow its introduction into the country's healthcare system.
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04/11/2019 08:53
04/11/2020 16:14
