Eisai and Biogen said the FDA has extended the review of the supplemental Biologics License Application for a once-weekly subcutaneous starting-dose regimen of LEQEMBI (lecanemab-irmb) in early Alzheimer’s disease, setting a new PDUFA date of August 24, 2026.
Written By: Sana Khan BPharm
Reviewed By: Pharmacally Editorial Team
Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental Biologics License Application (sBLA) seeking approval of a once‑weekly subcutaneous formulation of LEQEMBI (lecanemab‑irmb) as a starting dose for patients with early Alzheimer’s disease.
The FDA assigned a new Prescription Drug User Fee Act (PDUFA) action date of August 24, 2026, extending the review timeline by three months. According to the companies, the extension followed the FDA’s request for additional information during the ongoing review process. The agency classified the submission as a major amendment to the sBLA, which allows additional time to complete its evaluation of the newly submitted materials. Eisai and Biogen stated that the FDA has not raised concerns regarding the approvability of LEQEMBI IQLIK as an initiation (starting‑dose) therapy.
The application seeks approval of a once‑weekly subcutaneous injection of lecanemab‑irmb, marketed in the United States as LEQEMBI IQLIK, for use as a starting dose in patients with early Alzheimer’s disease. The companies noted that the filing is supported by clinical data evaluating subcutaneous administration of LEQEMBI across multiple studies and dosing regimens.
The update follows the FDA’s approval of the subcutaneous maintenance‑dosing regimen for LEQEMBI on August 26, 2025. Eisai and Biogen said the proposed starting‑dose regimen could provide additional flexibility in the administration of anti‑amyloid therapy.
LEQEMBI is currently approved in more than 50 countries and regions worldwide for the treatment of early Alzheimer’s disease, according to the companies. The companies added that they will continue discussions with the FDA during the review process and remain focused on advancing additional administration options for patients and caregivers.
In addition to the ongoing U.S. review of the starting-dose regimen, regulatory momentum for subcutaneous LEQEMBI has continued globally. China has accepted the Biologics License Application for subcutaneous LEQEMBI in early Alzheimer’s disease, while the U.S. FDA previously approved LEQEMBI IQLIK as a subcutaneous maintenance-dosing option for patients with early-stage disease.
LEQEMBI is indicated for the treatment of Alzheimer’s disease in patients with mild cognitive impairment or mild dementia, the population evaluated in clinical trials.
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About the Writer
Sana Jamil Khan (LinkedIn) is a B. Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.