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FDA Approves Eisai and Biogen’s Leqembi for Alzheimer’s Disease

First and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline.

The U.S. FDA approved the supplemental biologics license application (sBLA) for Eisai Co., Ltd., and Biogen Inc.’s LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use, making it the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease (AD). LEQEMBI demonstrated clinically meaningful slowing of cognitive and functional decline in a patient group generalizable to U.S. ...

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