China News Service, January 16 (Xinhua) According to a report by Japan's Kyodo News Agency on the 16th, the drug "Lecanemab" (Lecanemab), jointly developed by Biogen of the United States and Japan's Eisai, has achieved the effect of delaying the aggravation of Alzheimer's disease symptoms. confirmed.
At present, the two companies are striving to obtain approval within the year to realize the production and sales of the drug.
According to reports, this drug is suitable for patients with early Alzheimer's disease.
If the drug is approved, it will be the first cognitive impairment drug in Japan that can suppress the progression of the condition.
It is reported that the "beta amyloid protein" accumulated in the brain is the cause of Alzheimer's disease, and the effective mechanism of "lencanezumab" is to adhere to and remove such proteins.
In the clinical trial, the experimental group was infused with a drip every two weeks and injected with a dose consistent with body weight, while the control group was only injected with a placebo.
A year and a half later, comparing the results of the two groups found that the drug was 27% effective in inhibiting the worsening of symptoms.
The analysis showed that the proportion of suspected side effects of cerebral edema and cerebral hemorrhage in the brain images of patients in the experimental group was 12% to 17% higher than that in the control group.
Although most of them are asymptomatic and mild symptoms, the report said that if this drug is used together with anticoagulants for diseases such as cerebral infarction, the risk of cerebral hemorrhage may increase.
According to reports, the standard price of Eisai in the United States is 26,500 US dollars a year, and it is expected to be more expensive in Japan.
Faced with the pressure that high prices may bring to medical finances, Eisai emphasized that delaying the deterioration of the disease through drugs can reduce the time and money spent on nursing by patients' families.
According to reports, two Japanese and American companies had previously developed the drug "Aduranumab" with the same mechanism, but the expert group of the Ministry of Health and Labor made a decision not to approve it in December 2021 because "it is difficult to clearly judge the effectiveness." ".
According to media reports, Japan's Eisai has submitted an application to the Ministry of Health and Labor for the production and sale of the drug on the 16th. The US Food and Drug Administration has also recently authorized accelerated approval of the drug, but it will take some time for it to be widely used.