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.
(Reporting by Satoshi Sugiyama; Editing by Rashmi Aich)
