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Following the U.S. FDA, Japanese authorities also officially approve dementia drug ‘Lechembe’

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After price discussion, use is expected in medical settings as early as this year.

Following the United States, Japan also approved the manufacture and sale of the dementia treatment new drug ‘Lechembe’ on the 25th.

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According to Jiji News, Sankei Shimbun, etc., Japan’s Ministry of Health, Labor and Welfare officially approved the manufacture and sale of ‘Lechembe (ingredient name: lecanemab)’, jointly developed by Biogen of the United States and Eisai of Japan, on this day. This is the first time that a drug to suppress the progression of dementia has been approved in Japan.

Regarding this, Eisai CEO Haruo Naito commented, “We have been able to open a new page in the history of Alzheimer’s treatment.”

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Lecanemab removes the brain protein beta amyloid, which is believed to be the cause of Alzheimer’s disease.

Lechembe, which is administered intravenously once every two weeks, showed that the decline in cognitive ability in patients receiving this drug progressed about 27% later than in the placebo (fake drug) group, according to the results of a phase 3 clinical trial involving 1,795 patients. Eisai explained that it has the effect of slowing the progression of the disease by about seven and a half months.

However, it cannot be expected to reverse the condition or completely cure it. Side effects such as brain swelling have also been reported.

Those receiving Lechemvy are patients with early Alzheimer’s disease and those with mild cognitive impairment in the previous stages. It is estimated that there are about 5 to 6 million people in Japan. Eisai estimates that only about 1% of that scale will use Rekembi.

Previously, the U.S. Food and Drug Administration (FDA) also officially approved Lechembe on July 6 (local time). The standard price is $20,650 (about 28 million won) per year.

In Japan, the process to determine the price of Lechembi will also be carried out in the future. After the Japan Central Social Insurance Medical Council, an advisory body to the Ministry of Health, Labor and Welfare, discussed fair prices, which are drug prices, it is expected to be used in medical settings as early as this year. Public health insurance applies.

Source: Donga

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