Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that the US Food and Drug Administration (FDA) has cleared their supplemental Biologics License Application (sBLA) for once every four weeks Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing. The drug is approved in the US for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (early AD).
Approval Details and Dosing Regimen
The approval means that, after an 18-month initiation phase of once every two weeks, patients may transition to a maintenance dosing regimen of 10 mg/kg once every four weeks or continue with the regimen of 10 mg/kg once every two weeks. The FDA’s endorsement is supported by modeling of observed data from the Phase II study (Study 201) and its long-term extension (LTE), as well as the Clarity AD study (Study 301) and its LTE study. Modeling simulations predict that transitioning to once every four weeks maintenance dosing after 18 months of once every two weeks treatment will maintain clinical and biomarker benefits of therapy.
Future Prospects and Subcutaneous Autoinjector
Relatedly, Leqembi subcutaneous autoinjector (SC-AI) is awaiting FDA decisions by August 31, 2025. This development underscores Eisai and Biogen’s ongoing commitment to advancing treatment options for Alzheimer’s disease, addressing significant unmet medical needs and improving patient outcomes.-Fineline Info & Tech
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