Eisai Co., Ltd, (4523.T,ESALY.PK,ESALF.PK), a Japanese commercial-stage biotechnology firm and Biogen Inc. (BIIB) said the U.S. Food and Drug Administration (FDA) has accepted for priority review Eisai's Supplemental Biologics License Application (sBLA) for lecanemab-irmb or LEQEMBI subcutaneous autoinjector or SC-AI, LEQEMBI IQLIK, as a weekly starting dose for early Alzheimer's disease.
The Prescription Drug User Fee Act (PDUFA) action for the sBLA has been granted for May 24, 2026.
Lecanemab is a humanised immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta.
Lecanemab was developed through a collaboration between the Japanese pharmaceutical company Eisai and the American biotech firm Biogen. This initially emerged from earlier research by the Swedish company BioArctic AB, which provided Eisai with the antibody for development and commercialisation.
In 2014, Eisai and Biogen had entered into a joint development and commercialisation agreement for lecanemab. Eisai is responsible for the clinical development, market approval applications, and commercialisation of products for Alzheimer's disease.
BioArctic has the right to commercialise lecanemab in the Nordic region and is currently preparing for commercialisation in the Nordics together with Eisai.
Notably In August 2025, the FDA approved LEQEMBI IQLIK 360 mg for weekly subcutaneous maintenance dosing after 18 months of IV treatment every two weeks.
The sBLA is supported by data from the Phase 3 Clarity AD open-label extension core study, which followed individuals with early AD for 18 months.
The study demonstrated that once-weekly administration of 500 mg of SC-AI achieved exposure equivalent to that of once-every-two-weeks IV administration, with similar clinical and biomarker benefits.
Subcutaneous administration demonstrated a safety profile with an incidence of systemic injection or infusion-related reactions of less than 2%.
If the FDA approves the LEQEMBI IQLIK 500 mg SC dosing regimen (two 250 mg injections), the autoinjector could be used to administer a once-weekly starting dose, as an alternative to the current bi-weekly intravenous (IV) dosing.
The subcutaneous formulation may reduce healthcare resources like infusion preparation and nurse monitoring associated with IV dosing.The injection time for the LEQEMBI IQLIK autoinjector is approximately 15 seconds per 250 mg injection.
LEQEMBI is currently approved in 53 countries and regions and is under regulatory review in 7 countries.
Alzheimer's disease in patients with mild cognitive impairment or mild dementia stage of disease is collectively referred to as early Alzheimer's disease.
According to Grand View Research, the global Alzheimer's therapeutics market size was estimated at $4.05 billion in 2022 and is anticipated to reach $15.19 billion by 2030, growing at a CAGR of 19.99% from 2023 to 2030.
Over the year, BIIB traded in a range of $110.04 and $190.20. BIIB closed Friday's trade at $171.59, down 1.27%.
Over the year, 4523.T traded in a range of 3,463 Japanese yen - 5,349.00 Japanese yen.4523.T is trading 1.77% down at 4,497 Japanese Yen in the Tokyo market
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