ENTRY 07 OF 07 · SUBCUTANEOUS INITIATION DOSING

Leqembi Iqlik, subcutaneous initiation

Approved Leqembi Iqlik (lecanemab) · case BUILT

Sponsor: Eisai Inc. Supplement approval letter, p. 1
Action date: July 13, 2026 Supplement approval letter, p. 5
Basis: Subcutaneous starting dose, 500 mg weekly Supplement approval letter, p. 1
Committee: No advisory committee is mentioned in the letter Supplement approval letter
Confirmatory: Noneno postmarketing requirement in the letter

What the sponsor asked the agency to accept

As the FDA restates it.

[sponsor's request as restated in the FDA review: not loaded]

What the agency said

T3 · ARIAConsistent

IQI-T3-1

Patients who are apolipoprotein E ε4 (ApoE ε4) homozygotes (approximately 15% of Alzheimer’s disease patients) treated with this class of medications, including LEQEMBI, have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers.

Prescribing information (label) · PDF p. 3 · action of Jul 13, 2026 · fda.gov ↗

Compared to IQM-T3-2, Leqembi Iqlik, subcutaneous maintenance, Aug 29, 2025.