Talk Bio

Biogen and Eisai have received FDA approval for a subcutaneous (under-the-skin) formulation of Leqembi (lecanemab) as a starter dose for early Alzheimer’s disease. The new subcutaneous version, branded LEQEMBI IQLIK®, is administered weekly via an autoinjector and can be used both to initiate treatment and for ongoing maintenance dosing. This approval, granted in mid-July 2026, allows patients to start Leqembi therapy with a subcutaneous injection rather than the previous intravenous (IV) infusion, and to continue the entire course of treatment at home, which is a first among anti‑amyloid Alzheimer’s therapies. Clinical data from the Phase 3 Clarity AD trial and related sub‑studies showed that the weekly 500 mg subcutaneous dose achieves drug exposure comparable to the IV initiation regimen, with similar clinical and biomarker effects and a comparable safety profile. Common side effects include localized injection‑site reactions (erythema, swelling, pain) and some systemic reac...