Japan approves Alzheimer's treatment Leqembi by Eisai and Biogen

28 September 2023

Satoshi Sugiyama and Pratik Jain / Reuters

Japan's Eisai (4523.T) said on Monday its Alzheimer's treatment developed with Biogen (BIIB.O), Leqembi, was approved by the country's health ministry, making it the second nation after the United States to clear its use.

It can now be used in Japan as a treatment for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer's disease.

Leqembi is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of Alzheimer's patients.

The drug is the first treatment shown to slow progression of the disease for people in the earlier stages of Alzheimer's.

A health ministry panel in Japan had in August given its nod for the drug, a move that followed a standard approval from the U.S. Food and Drug Administration (FDA) in July.

The first FDA-approved disease-modifying Alzheimer's drug, Aduhelm, was also developed by partners Eisai and Biogen, but Medicare coverage restrictions have severely limited its use.

Eisai said it will conduct a post-marketing special use results survey in all patients administered with Leqembi until it collects enough data from an undisclosed number of patients.

Such a move is in accordance with an approval condition by Japan's health ministry. In the US, health regulators have placed warning on the drug's label, flagging the risk of potentially dangerous brain swelling for Alzheimer's drugs in the same class.

An Eisai executive said in August the company expected to begin marketing Leqembi in Japan in about 60 days after receiving insurance reimbursement approval from the national health system.

In Japan, Eisai and Biogen Japan will co-promote the drug, with Eisai distributing the product as the marketing authorization holder.



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