Eisai Co Ltd, ESALY.PK, ESALF.PK, 4523.T, EII.SG, FDA Calendar, PDUFA Date

Company Name	Eisai Co Ltd ESALY.PK, ESALF.PK, 4523.T, EII.SG
Drug Name	LEQEMBI IQLIK (sBLA)
Event Name	FDA decision on LEQEMBI IQLIK, as a weekly starting dose, for the treatment of early Alzheimer’s Disease
Event Date	05/24/2026
Outcome Date
Outcome	FDA requests additional information during the review process of LEQEMBI IQLIK and extends the decision by three months to Aug 24, 2026
Drug Status	Priority review Eisai leads the global development and regulatory filings of LEQEMBI, co-commercialises and co-promotes it with Biogen, and has final decision-making authority.
Rival Drugs
Market Potential
Other Approvals	EQEMBI IQLIK is a subcutaneous autoinjector, which is already indicated for maintenance dosing to treat Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in the U.S.
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