Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced the completion of a rolling submission of a Biologics License Application (BLA) for their co-developed Alzheimer’s disease drug Leqembi (lecanemab) to the U.S. Food and Drug Administration (FDA). The submission seeks approval for Leqembi as a subcutaneous autoinjector for weekly maintenance dosing in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of Alzheimer’s disease (collectively referred to as early AD), an indication that has been granted Fast Track Designation by the FDA.
The BLA submission is supported by data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data, demonstrating that treatment with lecanemab resulted in a 27% reduction in clinical decline on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months compared to placebo. If approved, the Leqembi autoinjector would enable at-home or medical facility administration, with an expected injection process duration of approximately 15 seconds.- Flcube.com
