Japan approves Alzheimer treatment Leqembi by Eisai and Biogen

[September 25, 2023]  TOKYO (Reuters) - Japan's Eisai said on Monday the country's health ministry had approved its Alzheimer treatment Leqembi, co-developed with U.S.-based Biogen.

The development comes after a health ministry panel recommended the drug's approval in August, followed by standard approval from the U.S. Food and Drug Administration (FDA) in July.

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

The U.S. health regulators, though, 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 within about 60 days of receiving insurance reimbursement approval from the country's national health system.

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Eisai/Handout via REUTERS /File Photo

(Reporting by Satoshi Sugiyama; Editing by Rashmi Aich)

[© 2023 Thomson Reuters. All rights reserved.]This material may not be published, broadcast, rewritten or redistributed.  Thompson Reuters is solely responsible for this content.