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FDA Grants Priority Review to Leqembi Autoinjector for Weekly At-Home Starting Dose

FDA acceleration follows company data indicating IV‑equivalent exposure with a weekly autoinjector that could move initiation to the home.

Alzheimer’s disease is characterised by amyloid beta and tau pathologies, driven by ongoing neurotoxicity from protofibrils. Credit: StanislavSukhin / Shutterstock.com.
Eisai and Biogen’s subcutaneous Leqembi given FDA Priority Review for early Alzheimer’s

Overview

  • Eisai and Biogen’s supplemental application for Leqembi Iqlik as a starting regimen for early Alzheimer’s has been accepted under Priority Review.
  • The FDA set a Prescription Drug User Fee Act action date of May 24, 2026 for a decision on the subcutaneous initiation dose.
  • The proposed starting regimen is 500 mg once weekly delivered as two 250 mg injections, offering an alternative to bi‑weekly intravenous initiation.
  • Company-reported Clarity AD and open‑label extension results indicate equivalent exposure to IV dosing with similar clinical and biomarker effects and a comparable safety profile, with under 2% systemic injection or infusion reactions.
  • If approved, patients could begin and continue treatment at home with injections that take about 15 seconds, potentially reducing infusion‑center demand, and Leqembi is already authorized in 53 markets with U.S. approval for subcutaneous maintenance.