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FDA Clears At-Home Leqembi Injection for Weekly Maintenance in Early Alzheimer’s

The new 360 mg weekly autoinjector lets eligible patients continue therapy after 18 months of infusions with comparable benefits and safety.

Overview

  • U.S. availability begins October 6, 2025, with the device administering the full dose in about 15 seconds.
  • After 18 months of 10 mg/kg IV every two weeks, patients can switch to the weekly injection or continue IV at 10 mg/kg every four weeks.
  • Clarity AD open-label extension data show maintained clinical outcomes and biomarker improvements after switching from infusions to the weekly shot.
  • Systemic reactions occurred in less than 1% with the injection versus about 26% with infusions, while roughly 11% reported mild-to-moderate injection-site reactions.
  • Amyloid-related imaging abnormality rates were comparable to IV, so MRI monitoring and ARIA risk management remain part of treatment.