On August 1st, the discussion on the manufacturing and sales approval of the Alzheimer's drug 'Donanemab' will take place, with the possibility of approval in September.

2024/07/21 18:17
The Ministry of Health, Labour and Welfare decided to discuss the approval of manufacturing and sales of the Alzheimer's drug 'Donanemab' by eli lilly and co on August 1st at the expert committee. If approved, there is a possibility of approval in September. Donanemab is an intravenous drug that removes the abnormal protein 'amyloid beta' accumulated in the patient's brain, aiming to suppress the progression of the disease. The target includes patients in the early stages of Alzheimer's disease, including those with mild cognitive impairment (MCI), which is a pre-dementia stage. Developed by Japanese pharmaceutical companies like Eisai, it is the same type of medicine as 'Lecanemab,' which has been used domestically since December last year.
According to eli lilly and co, in a clinical trial involving about 1,700 participants, the group treated with Donanemab showed a 22% reduction in decline in cognitive function and ability to lead daily life compared to the group treated with a placebo after one and a half years. In the earlier stage group, the reduction was 35%.
The company applied for approval to the Ministry of Health, Labour and Welfare in September last year. The U.S. Food and Drug Administration (FDA) approved it on July 2nd this year.