On January 26, 2025, the U.S. Food and Drug Administration (FDA) approved monthly maintenance dosing for Eisai Co., Ltd. and Biogen Inc.'s Alzheimer's drug, Leqembi (lecanemab-irmb). This approval allows for a transition to a once every four weeks maintenance dosing regimen after 18 months of the initial bi-weekly intravenous (IV) treatment phase.
The supplemental Biologics License Application (sBLA) was based on modeling of observed data from the Phase 2 study (Study 201) and its long-term extension, as well as the Clarity AD study (Study 301) and its long-term extension. Modeling simulations predict that this monthly maintenance dosing will effectively maintain the clinical and biomarker benefits of therapy.
This approval is expected to make treatment with Leqembi more manageable for patients and their care partners, potentially improving adherence to long-term therapy. By offering a less frequent dosing schedule, the new regimen can reduce the logistical burden associated with regular infusions, thereby facilitating broader access and continued treatment for individuals with early Alzheimer's disease.
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