Eisai Completes Rolling Submission to FDA for Lecanemab Approval

Eisai has completed a rolling submission to the U.S. Food and Drug Administration (FDA) to seek approval for lecanemab (BAN2401), an investigational antibody for the treatment of early Alzheimer’s disease accompanied by beta-amyloid deposits in the brain. The request — made in the form of a biologics license application (BLA) — if accepted by the FDA will be reviewed under the agency’s accelerated approval pathway, which allows for earlier approval of therapies to treat serious…

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