Rolling submission to FDA completed for subcutaneous Leqembi (lecanemab-irmb) for treatment of Alzheimer's disease- Eisai + Biogen

Leqembi is indicated for the treatment of Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set.

The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data. If approved by the FDA, the Leqembi autoinjector could be used to administer Leqembi at home or at medical facilities, and the injection process is expected on average to take about 15 seconds. As part of the subcutaneous autoinjector 360 mg weekly maintenance regimen under review, patients who have completed the biweekly intravenous (IV) initiation phase would receive weekly doses that maintain effective drug concentrations to sustain the clearance of highly toxic protofibrils which can continue to cause neuronal injury even after the amyloid-beta (Aβ) plaque has been cleared from the brain.

AD is an ongoing neurotoxic process that begins before and continues after plaque deposition. Data suggest that early and continuing treatment may prolong the benefit of therapy even after plaque is cleared from the brain. This SC autoinjector is expected to be easier for patients and their care partners to use and may reduce the need for hospital or infusion site visits and nursing care compared to IV administration. In addition to potentially maintaining the clinical and biomarker benefits, subcutaneous maintenance dosing may be more convenient for patients and their care partners to continue the treatment.

Leqembi is approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, UAE and Great Britain. Eisai has also submitted applications for approval of lecanemab in 10 countries and regions, including the European Union (EU). The FDA accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly Leqembi  IV maintenance dosing in June 2024 and set a PDUFA action date for January 25, 2025.