FDA Advisers to Weigh Full Approval for Eisai-Biogen’s Alzheimer’s Drug

FDA Advisers to Weigh Full Approval for Eisai-Biogen’s Alzheimer’s Drug
The Alzheimer's drug Leqembi in an undated handout image obtained on Jan. 20, 2023. Eisai/Handout via Reuters
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The Food and Drug Administration (FDA) plans to hold a meeting of its outside experts in June to discuss full approval of the Alzheimer’s drug developed by Eisai Co. Ltd. and Biogen Inc., according to a federal filing on Monday.

The drug, Leqembi was granted accelerated approval by the FDA in January for patients in the earliest stages of the mind-wasting disease.