Eisai-Biogen Alzheimer's Drug Data Confirms Benefits: FDA

By Leroy Leo and Khushi Mandowara - U.S. Food and Drug Administration staff on Wednesday said data from a late-stage trial of Eisai and Biogen's Alzheimer's disease drug suggests it offered a meaningful benefit to patients and safety concerns likely would not hamper its chances of a traditional approval.

Analysts said the documents seemed to suggest approval for the drug. The FDA decision is expected by July 6. Eisai's application for a full approval is based on data showing Leqembi slowed the rate of cognitive decline in patients with early Alzheimer's by 27% compared to a placebo. The staff asked panelists to discuss the risk of serious side effects associated with the use of Leqembi in patients with a hard to diagnose condition called cerebral amyloid angiopathy, in which the protein amyloid that the drug targets builds up in the walls of arteries in the brain.

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