Eisai and Biogen Report US FDA Approval of Leqembi Iqlik as an Initiation Dose for Early Alzheimer’s Disease
Shots:
- The US FDA has approved an sBLA for Leqembi Iqlik (lecanemab‑irmb, SC) as an initiation dose administered as 500mg given QW as two 250mg injections, each delivered in ~15secs for the treatment of early Alzheimer’s disease
- Approval was supported by clinical data across multiple studies, with Clarity AD LTE sub-studies showing QW SC Leqembi achieved exposure comparable to IV dosing, supporting similar efficacy and amyloid removal
- Leqembi Iqlik for initiation dosing is expected to launch in the US in late Aug 2026. Eisai leads global development & regulatory submissions, co-commercializes the product with Biogen, and retains final decision-making authority
Ref: Eisai | Image: Eisai & Biogen | Press Release
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