LEQEMBI IQLIK (lecanemab-irmb)(at-home injection)

July 13, 2026: Eisai Co., Ltd. and Biogen Inc. (NASDAQ: BIIB) announced the FDA approved a supplemental BLA for once-weekly lecanemab-irmb subcutaneous injection (LEQEMBI IQLIK) as an initiation dose for adults with early Alzheimer’s disease (mild cognitive impairment or mild dementia due to AD).

LEQEMBI IQLIK is delivered via autoinjector as 500 mg once weekly (two 250 mg injections; ~15 seconds each). It can also be used for maintenance dosing at 360 mg once weekly after 18 months of IV or SC treatment, and patients may switch between IV infusion and SC injection across the course of therapy. U.S. launch as an initiation dose is planned for late August 2026.

Approval was supported by multiple studies including Phase 3 Clarity AD long-term extension sub-studies showing once-weekly SC achieved exposure comparable to IV, supporting similar clinical/biomarker benefits. Safety was generally similar to IV; injection-related reactions were mostly localized. The release reiterates ARIA risks (e.g., ARIA observed 21% with LEQEMBI vs 9% placebo; symptomatic ARIA 3%) and notes higher ARIA rates in ApoE ε4 homozygotes.