LEQEMBI IQLIK (lecanemab-irmb) subcutaneous initiation regimen
Alzheimer's disease · Adults with mild cognitive impairment or mild dementia due to Alzheimer's disease
BIIB · Biogen
监管认定
完整时间线
7 个里程碑Original PDUFA date superseded by early approval
FDA had extended the PDUFA action date from May 24 to August 24 after determining that additional information submitted during review constituted a major amendment. The agency approved the sBLA on July 13, before the revised goal date.
Eisai — PDUFA review extension to August 24↗FDA approved subcutaneous initiation dosing
FDA approved LEQEMBI IQLIK as a once-weekly subcutaneous initiation regimen for early Alzheimer's disease. The approved 500 mg starting dose is administered as two 250 mg autoinjector injections.
Eisai — FDA approval of LEQEMBI IQLIK initiation dosing↗FDA extended the review by three months
FDA requested additional information and treated the response as a major amendment, moving the PDUFA action date from May 24 to August 24, 2026. Eisai and Biogen said FDA had not raised approvability concerns at that time.
Biogen — FDA Priority Review extension↗FDA accepted the sBLA with Priority Review
FDA accepted the sBLA for LEQEMBI IQLIK as a weekly subcutaneous starting dose and initially assigned a May 24, 2026 PDUFA action date. The application was supported by subcutaneous dosing data, including Phase 3 Clarity AD open-label extension substudies.
Eisai — sBLA acceptance and Priority Review↗相关新闻
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