Eisai Starting Rolling Submission to FDA for Lecanemab Approval

Eisai Starting Rolling Submission to FDA for Lecanemab Approval

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Eisai Starting Rolling Submission to FDA for Lecanemab Approval

Eisai has started work on a rolling submission to the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA) for lecanemab (BAN2401), its antibody treatment for early Alzheimer’s disease. As a rolling submission, Eisai will submit each portion of its application as it is completed, rather than waiting for its entire package to be done before handing it over to federal regulators, as is normally the process. “The lecanemab rolling BLA submission…

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