Eisai Co., Ltd. (Headquarters: Tokyo) and Biogen Inc. (Headquarters: Cambridge, Massachusetts) announced the following joint statement regarding today¡¯s recommendation by Japan¡¯s First Committee on New Drugs of the Pharmaceutical Affairs and Food Sanitation Council of the Ministry of Health, Labour and Welfare that the manufacturing and marketing authorization application for lecanemab (product names: Leqembi 200 mg for intravenous infusion and Leqembi 500 mg for intravenous infusion) should be approved.

Joint Statement:

Today, the First Committee on New Drugs of the Pharmaceutical Affairs and Food Sanitation Council of the Ministry of Health, Labour and Welfare (MHLW) has recommended that lecanemab¡¯s manufacturing and marketing authorization application for the treatment of early Alzheimer’s disease should be approved, which is a major step forward in the treatment of Alzheimer¡¯s disease in Japan. We would like to express our deepest gratitude to all patients, caregivers, and healthcare professionals who participated in the lecanemab clinical trials. Once approved, we will do our best to appropriately deliver lecanemab, which was the first to demonstrate a clear reduction in the rate of Alzheimer¡¯s disease progression and slowing of cognitive and functional decline, as a new treatment option for patients suffering from early Alzheimer¡¯s disease in Japan.