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MHLW Committee Recommends Approval Of Eisai And Biogen’s Leqembi® (Lecanemab)

Aug 21, 2023

The Japan Times has reported that a Ministry of Health, Labour and Welfare (MHLW) committee has recommended approval of Eisai/Biogen’s Leqembi® (lecanemab).  The article notes that the committee’s endorsement will be followed by approval by the Health Minister in the coming days.

On 6 July 2023, Leqembi® was approved by the FDA in the US to treat Alzheimer’s disease.  The product label notes it should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.