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.