Developed by Japanese drugmaker Eisai Co. and U.S. biotechnology firm Biogen Inc., the drug's approval in Japan comes two months after it was endorsed by the U.S. Food and Drug Administration.
Prime Minister Fumio Kishida, who announced Japan's approval of Leqembi on Monday, called it “a breakthrough” and said that the “treatment of dementia has now entered a new era.” According to the health ministry, Japan's number of dementia patients who are 65 years of age or older will rise to 7 million in 2025, from the current 6 million.
Eisai said it will conduct a post-marketing special use survey in all patients administered the drug until enough data is collected from unspecified number of patients under Japanese health ministry procedures.
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