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FINWIRES

FDA Approves Eisai, Biogen's LEQEMBI Injection for Early Alzheimer's

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The US Food and Drug Administration has approved Eisai (TYO:4523) and Nasdaq-listed Biogen's supplemental Biologics License Application for LEQEMBI IQLIK, a once-weekly subcutaneous injection administered via autoinjector for early Alzheimer's disease.

The new formulation is an at-home alternative to intravenous infusion from treatment initiation, with a 500 mg weekly dose given as two 15-second injections, according to a Tokyo bourse filing on Monday.

The approval allows patients to switch between IV and subcutaneous administration as needed.

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