On October 31, 2024, Eisai Co., Ltd. and Biogen Inc. announced that Eisai completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector for weekly maintenance dosing. This submission was granted Fast Track designation by the FDA, which aims to expedite the development and review process for drugs addressing serious conditions and unmet medical needs.
LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease. If approved, the subcutaneous autoinjector would allow for at-home administration, with the injection process expected to take approximately 15 seconds. This new formulation is designed to maintain the clinical and biomarker benefits observed with intravenous administration, potentially reducing the need for hospital or infusion site visits.
The BLA is based on data from the Clarity AD (Study 301) open-label extension and modeling of observed data. The availability of a subcutaneous option is expected to enhance convenience for patients and their care partners, thereby simplifying the treatment pathway for early AD. The FDA will set a Prescription Drug User Fee Act (PDUFA) action date upon acceptance of the BLA.
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