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Australia Approves Leqembi for Early Alzheimer’s With Genetic Restrictions

The TGA reversed an earlier non-approval after a safety review addressed risks tied to APOE4 status.

Overview

  • Use is limited to adults with mild cognitive impairment or mild dementia due to Alzheimer’s who are APOE ε4 non-carriers or heterozygotes with confirmed amyloid pathology.
  • The decision follows a February 2025 knockback and an Administrative Review Tribunal review requested by Eisai that led to an agreement with the regulator.
  • Australia becomes the 50th country to register the therapy, which is administered as a one-hour intravenous infusion every two weeks to target amyloid.
  • Clinicians say the drug can slow decline in early disease, but monitoring for brain swelling or microbleeds is required, with MRI scans during treatment.
  • The medicine costs about A$39,974 a year before infusion and imaging fees, and a Pharmaceutical Benefits Scheme listing has not been granted.