TOKYO (AP) – Japan’s health ministry has approved Leqembi, an Alzheimer’s drug jointly developed by Japanese and U.S. pharmaceutical companies. It’s the first drug to treat the disease in a country with a rapidly aging population.
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 approved by the U.S. Food and Drug Administration.
Designed for patients with mild dementia and other symptoms in the early stages of Alzheimer’s disease, Leqembi is the first drug that can modestly slow their cognitive decline.
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.
Kishida has pledged to step up support for the growing number of dementia patients and their families, and will launch a panel this week to discuss measures for a dementia-friendly society.
According to the health ministry, the number of dementia patients in Japan aged 65 or older is expected to rise to 7 million by 2025, from 6 million at present.
However, the drug does not work for everyone and, like other Alzheimer’s drugs that target plaques in the brain, can in rare cases cause dangerous side effects such as brain swelling and bleeding.
Eisai said that until it has collected enough data from an unspecified number of patients, it will conduct a post-marketing special-use study in all patients who have been administered the drug in accordance with Japanese health ministry procedures.
The drug is expected to be ready for clinical use by the end of the year and will be partially covered by health insurance. The price has yet to be determined, but is expected to be expensive, Kyodo News reported.
