Overview
- Leqembi Iqlik, a 360 mg once‑weekly subcutaneous autoinjector from Eisai and Biogen, won FDA approval for maintenance dosing after completion of the IV initiation course.
- Labeling allows eligible patients to continue monthly IV infusions or switch to the at‑home autoinjector, which delivers a dose in about 15 seconds.
- Clarity AD open‑label extension data show that switching to weekly subcutaneous maintenance preserves clinical and biomarker benefits comparable to continued IV therapy.
- Safety profiles were similar overall, with systemic reactions in less than 1% of subcutaneous users versus about 26% with IV; local injection‑site reactions occurred in roughly 11%, and ARIA rates were comparable, necessitating ongoing imaging surveillance.
- Eisai said a year of Iqlik will cost $19,500 for uninsured patients versus $13,316 for IV maintenance, and Medicare coverage continues to require registry enrollment, factors likely to influence uptake.