FDA extends review of Biogen, Eisai’s Leqembi weekly subcutaneous starting dose by 3 months

Biogen Inc.

Biogen Inc.

BIIB

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  • FDA extended review of supplemental application for once-weekly LEQEMBI IQLIK subcutaneous injection as starting dose for early Alzheimer’s disease by three months, setting new PDUFA action date of Aug. 24, 2026.
  • Extension followed FDA request for additional information, which agency classified as major amendment, resetting regulatory timeline.
  • FDA has not raised approvability concerns to date, keeping potential US label expansion on track but delayed.


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