Komori
Other Disclosures4523Eisai Co.,Ltd.Pharmaceuticals

Approval Granted in Japan for Leqembi Subcutaneous 250 mg Pen, a Subcutaneous Formulation of the Early Alzheimer’s Disease Treatment Leqembi

Japan has approved Leqembi Subcutaneous 250 mg Pen, a subcutaneous formulation of Leqembi. This adds weekly at-home subcutaneous administration as an option alongside the existing once-every-two-weeks intravenous administration at medical institutions.

Worth reading
75Important
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Improvement
Direction inferred from the company’s description.
Scale
500
mg (once weekly, 2 injections in total)
Wording
Conditional
How definitive the wording is.

Announced details

Leqembi Subcutaneous 250 mg PenLeqembi (lecanemab)
Applicable field (uses covered by this announcement)

Slowing the progression of mild cognitive impairment and mild dementia due to Alzheimer's disease (early Alzheimer's disease)

Contract Date2014 (partnership for the joint development and commercialization of Alzheimer's disease treatments)
What the company reported numerically
Quantitative Effects

Approximately 15 seconds per pen. Incidence of systemic reactions associated with injection: 1.4%.

Usage history

Leqembi has been approved in 53 countries and regions and is under application review in 6 countries. Approval of the SC formulation is the third such approval worldwide.

Relationship between the counterparty and the company
Eisai Co.,Ltd.4523
Relationship with the Company

Eisai and Biogen have been partners in the joint development and commercialization of Alzheimer's disease treatments since 2014, and will jointly commercialize and promote lecanemab. Eisai leads development and regulatory submissions globally and holds final decision-making authority.

CounterpartyBiogen Inc. (Nasdaq: BIIB)

A biotechnology company headquartered in Cambridge, Massachusetts, United States. Founded in 1978, it is led by CEO Christopher A. Viehbacher.

Impact on Business Performance

The impact on the earnings forecast for the fiscal year ending March 2027 is minor, and there is no change to the earnings forecast announced on 15 May 2026.

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

Results from the 18-month core Clarity AD study, the subcutaneous administration substudy of the long-term extension (LTE) study, and integrated modeling and simulation analyses. Reference articles were published in Nat Commun, Int J Mol Sci, and Molecular Psychiatry.

Announced details
ItemDetails
Names of Products / Services CoveredLeqembi Subcutaneous 250 mg Pen, Leqembi (lecanemab)
CounterpartyBiogen Inc. (Nasdaq: BIIB)
Counterparty overviewA biotechnology company headquartered in Cambridge, Massachusetts, United States. Founded in 1978, it is led by CEO Christopher A. Viehbacher.
Relationship with the CompanyEisai and Biogen have been partners in the joint development and commercialization of Alzheimer's disease treatments since 2014, and will jointly commercialize and promote lecanemab. Eisai leads development and regulatory submissions globally and holds final decision-making authority.
Contract Date2014 (partnership for the joint development and commercialization of Alzheimer's disease treatments)
Applicable areaSlowing the progression of mild cognitive impairment and mild dementia due to Alzheimer's disease (early Alzheimer's disease)
Quantitative EffectsApproximately 15 seconds per pen. Incidence of systemic reactions associated with injection: 1.4%.
Usage historyLeqembi has been approved in 53 countries and regions and is under application review in 6 countries. Approval of the SC formulation is the third such approval worldwide.
Impact on Business PerformanceThe impact on the earnings forecast for the fiscal year ending March 2027 is minor, and there is no change to the earnings forecast announced on 15 May 2026.
SourceResults from the 18-month core Clarity AD study, the subcutaneous administration substudy of the long-term extension (LTE) study, and integrated modeling and simulation analyses. Reference articles were published in Nat Commun, Int J Mol Sci, and Molecular Psychiatry.
Items this document does not state (8)
Contract ValueOffering priceLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scale

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

To enable at-home administration, reduce administration time, the burden of hospital visits, and constraints on going out and traveling, and improve the efficiency of healthcare resources.

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Approval Granted in Japan for Leqembi Subcutaneous 250 mg Pen, a Subcutaneous Formulation of the Early Alzheimer’s Disease Treatment Leqembi | Eisai Co.,Ltd. (4523) timely disclosure | Komori