FDA clears at-home Leqembi injection, transforming Alzheimer’s maintenance care

Eisai and Biogen’s Alzheimer’s drug Leqembi now has FDA approval for a once-weekly autoinjector, Leqembi IQLIK, the first amyloid-targeting therapy that can be administered at home.

Why it matters: This self-injection option brings easier access, especially for rural patients, reduces burden on infusion centers, and helps Alzheimer’s patients stay in treatment during the disease’s earliest and most treatable stages.

Backstory: Leqembi was initially approved as an IV infusion for early-stage Alzheimer’s. Patients begin with 18 months of biweekly IV initiation before moving to maintenance. The new IQLIK option allows maintenance treatment at home after this period.

Big picture: Leqembi IQLIK is a key step in Eisai’s goal to generate $1.7B–$1.9B in annual sales by 2027. It also reinforces Leqembi’s edge over rivals like Lilly’s Kisunla by offering continued protofibril clearance and a more patient-friendly delivery.

Zoom in: Upon testing, the subcutaneous dose of Legembi showed similar clinical and biomarker results as IV infusion in trials. This was measured by comparing numbers of Amyloid-related imaging abnormalities (ARIA), which were comparable across both formats. Not only this, but the subcutaneous injections had minimal side effects with only 1% of patients as opposed to 26% with IV administrated.

What´s next: The subcutaneous version of Legembi is set to launch on October 6th of this year for a list price of $19,500/year as opposed to the ~$13,316 for IV (not accounting for insurance discounts). Eisai expects a breakthrough designation and priority FDA review for the initiation formulation.