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Japan panel approves new Alzheimer’s drug

An expert panel of Japan's health ministry Monday approved an Alzheimer's drug jointly developed by Japanese drugmaker Eisai Co. and US partner Biogen Inc. (Shutterstock/file)
An expert panel of Japan's health ministry Monday approved an Alzheimer's drug jointly developed by Japanese drugmaker Eisai Co. and US partner Biogen Inc. (Shutterstock/file)
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21 Aug 2023 11:08:00 GMT9
21 Aug 2023 11:08:00 GMT9

TOKYO: An expert panel of Japan’s health ministry Monday approved an Alzheimer’s drug jointly developed by Japanese drugmaker Eisai Co. and US partner Biogen Inc.

Lecanemab, sold as Leqembi in the United States, is the first Alzheimer’s treatment confirmed effective in slowing the progression of symptoms. The ministry is expected to give it pharmaceutical approval soon.

Alzheimer’s disease is a condition in which a protein called amyloid beta accumulates in the brain, damaging nerve cells and weakening cognitive functions. Conventional drugs are effective in temporarily easing symptoms, but they cannot prevent affected brains from shrinking over time.

Lecanemab is believed to slow the progression of symptoms by removing amyloid beta. In a clinical trial, 18-month administration of the drug reduced the progression of symptoms by 27 pct in patients in the early stages of the disease compared with those given a placebo.

Meanwhile, 12.6 pct of those who received the treatment experienced brain swelling, and 17.3 pct cerebral microhemorrhage.

In January, Eisai filed an application with the ministry for approval to make and sell the new treatment in Japan.

The screening for the drug took about nine months, far shorter than one year as normally required, because the treatment was eligible for a priority review by the government-linked Pharmaceuticals and Medical Devices Agency.

The government will set the official price for lecanemab 60 to 90 days after the ministry’s pharmaceutical approval.

In the United States, where the drug was officially approved in July, its wholesale price stands at 26,500 dollars per patient annually.

Even if a high price is set for the drug in Japan, most of the costs will be covered with public health insurance under a system that sets a ceiling on out-of-pocket payments by patients.

According to the ministry, Japan had an estimated 6 million elderly people with dementia in 2020. While the use of lecanemab will be limited to patients with mild symptoms, there are concerns that it will financially strain the public health insurance system.

JIJI Press

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