Slow down cognitive decline by 27%!FDA Approves New Alzheimer’s Drug, But Side Effects Are Scary

Alzheimer’s disease is the most common dementia that affects memory; the picture is a photo of the situation, and the people in the picture have nothing to do with this article. (picture taken from freepik)

[Compilation of Chen Chengliang/Comprehensive Report]The Alzheimer’s drug “Lecanemab” jointly developed by the Japanese pharmaceutical company “Eisai” and the American biotechnology company “Biogen” was approved by the United States on the 6th. Approved by the Food and Drug Administration (FDA), it is the first drug shown to slow cognitive decline, though experts caution that use of the drug also increases the risk of side effects, including cerebral hemorrhage and cerebral edema.

Alzheimer’s disease is a neurodegenerative disease, accounting for 5 to 7 percent of dementia patients. The disease process is related to the deposition of amyloid protein in the brain and the defect of Tau protein. However, the development of related drugs mostly ends in failure.

The FDA approved lecanemab with conditions after an early study found that the drug reduced levels of the amyloid sticky protein in early-stage Alzheimer’s patients. The two companies will market the drug under the brand name “Leqembi”.

The drug is the first to definitively show in studies that reducing amyloid brings clinical benefit to patients, and while doctors say its effects are relatively modest and far from a cure, it is the first step in the decades-long search for Alzheimer’s disease. It is a milestone in a new treatment for dementia and could mark the beginning of a shift in the United States’ approach to the most common form of dementia and a leading cause of death.

The complete data of the Phase 3 clinical trial released by the two pharmaceutical companies in November last year showed that the drug significantly slowed down the cognitive decline of patients with early Alzheimer’s disease, which was 27% better than that of subjects taking a placebo. As for side effects, the rate of cerebral edema caused by Lecanemab was 12.6%, but only 2.8% had symptoms; the proportion of cerebral microbleeds was 17.3%; the placebo group had only 1.7% cerebral edema, 9% cerebral microbleeds, and even 2 people in the experiment die in the process.

Bart De Strooper, director of the British Dementia Research Institute, emphasized that Lecanemab is the first drug to provide a real treatment option for Alzheimer’s patients, “although the clinical benefit seems to be limited, it can be expected that if administered Over time, the effect will become more pronounced.”

The above-mentioned two companies began to cooperate in the development and sales of drugs for the treatment of this disease in 2014, including “Aduhelm” approved by the US Food and Drug Administration (FDA) last year. Controversy continues, and it has not been approved by the European Medicines Agency (EMA).

Lecanemab, like Aduhelm, is an intravenous antibody used to clear amyloids, but the former targets amyloids that have not yet accumulated. Peterson, the director of Alzheimer’s disease at the “Mayo Clinic” in the United States, believes that the side effect rate of Lecanemab is much lower than that of Aduhelm, which is within the range of “of course tolerable”.

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