On September 28, pharmaceutical companies Eisai and Biogen published a statement in which they presented the results of a clinical trial of their latest drug Lecanemab. Cognitive decline was slowed down among volunteers administered the drug.
The drug has not yet been approved for marketing, but the results of its clinical trials are assessed as optimistic. The deterioration of cognitive abilities in patients who took the drug was by 27%. lower than in those given placebo. The observed side effects did not pose a serious threat to the health or life of the respondents.
“In people with the earliest stages of Alzheimer’s, this treatment can change the course of their disease significantly. These results [badań klinicznych – red.] indicate that Lecanamab can give them more time in their full or near full capacity to participate in daily life, remain independent and make treatment decisions, “reads an excerpt from the Alzheimer’s Association’s statement posted on the association’s website.
Hope for patients in the early stages of the disease
1795 volunteers in the early stages of Alzheimer’s disease, whose brain was diagnosed with senile plaques, formed as a result of the deposition of a protein substance – beta-amyloid. It is believed that beta-amyloid deposition can block synaptic function, preventing the transmission of impulses from one nerve cell to another. Cells responsible for memory and orientation undergo degeneration, which translates into the formation of cognitive deficits.
During the study, the patients were divided into two groups: experimental and control. The former was given the drug every two weeks for 18 months. The second group received a placebo during this time.
The results of the research showed that in the group given Lecanemab, the cognitive decline was by 27%. lower than in the control group. According to the representative of Eisai, the drug started showing positive results after just six months.
As for side effects, 17% of them experienced side effects. taking the drug. This includes brain swelling or microcarcinomas. However, these symptoms are typical of the use of such agents. It should also be noted that they were also observed among 8.7 percent. volunteers given a placebo.
Eisai board member Ivan Cheung said during a press conference held on Tuesday: “This is the first overwhelmingly positive, large-scale clinical study that shows that it is indeed possible to slow down Alzheimer’s disease at a very early symptomatic stage.
Eisai and Biogen are seeking a marketing authorization for Lecanemab
Pharmaceutical company Eisai has already submitted an accelerated approval application to the US Food and Drug Administration (FDA) based on a previous smaller-scale clinical trial. Eisai officials said at the conference that they are currently waiting for this application to be processed, and only then plan to submit the results of the latest study to the FDA for full marketing authorization.
The companies also announced that they will present more detailed clinical trial results at a conference in San Francisco on November 29.
The New York Times, Alzheimers Association
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