Japan approves Leqembi, its first Alzheimer’s drug, after US approval

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Tokyo, Japan. Japan’s health ministry has granted approval for Leqembi, a drug developed for Alzheimer’s disease by Japanese pharmaceutical company Eisai Co. and U.S. biotechnology firm Biogen Inc. This marks a significant milestone as it’s Japan’s first drug for treating Alzheimer’s disease, a condition that is of increasing concern in a country with a rapidly aging population.

The approval in Japan follows the endorsement of Leqembi by the U.S. Food and Drug Administration (FDA) two months earlier. Leqembi is designed for patients with mild dementia and other early-stage Alzheimer’s symptoms, offering the potential to modestly slow cognitive decline.

Japanese Prime Minister Fumio Kishida, who announced the approval, hailed it as a “breakthrough” and a sign that “the treatment of dementia has now entered a new era.” Kishida has also promised increased support for the growing number of dementia patients and their families. He is set to convene a panel this week to discuss measures aimed at creating a more dementia-friendly society.

According to the health ministry, the number of dementia patients aged 65 or older in Japan is expected to increase from the current 6 million to 7 million by 2025.

However, it’s worth noting that Leqembi, like other drugs targeting Alzheimer’s-related brain plaques, doesn’t work for everyone and can have dangerous side effects, including brain swelling and bleeding, although these side effects are rare.

Eisai has committed to conducting a post-marketing special use survey involving all patients administered with the drug until enough data is collected, following Japanese health ministry procedures.

The drug will be partially covered by health insurance and is anticipated to be available for clinical use by the end of the year. Its price is yet to be determined but is expected to be relatively high, according to Kyodo News agency.

Haruo Naito, CEO of Eisai, expressed the company’s dedication to delivering Leqembi to those who need it and their families as a “new treatment.” He stated, “We aim to create an impact on issues surrounding dementia in Japanese society.”

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Si Venus L Peñaflor ay naging editor-in-chief ng Newsworld, isang lokal na pahayagan ng Laguna. Publisher din siya ng Daystar Gazette at Tutubi News Magazine. Siya ay isa ring pintor at doll face designer ng Ninay Dolls, ang unang Manikang Pilipino. Kasali siya sa DesignCrowd sa rank na #305 sa 640,000 graphic designers sa buong daigdig. Kasama din siya sa unang Local TV Broadcast sa Laguna na Beyond Manila. Aktibong kasapi siya ng San Pablo Jaycees Senate bilang isang JCI Senator.