Officials with Eisai Co., Ltd., and Biogen Inc. have announced the FDA nod for the supplemental biologics license application (sBLA) for once-every-4-weeks lecanemab-irmb (Leqembi) intravenous (IV) maintenance dosing.1
Lecanemab-irmb is indicated for the treatment of Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD) in the United States. After 18 months of the once-every-2-weeks initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every 4 weeks may be considered, or the regimen of 10 mg/kg once every 2 weeks may be continued.
The sBLA is based on modeling of observed data from the phase 2 study (Study 201) and its long-term extension (LTE) as well as the Clarity AD study (Study 301) and its LTE study. Data from the off-treatment period between the Study 201 core study and LTE showed that discontinuation of treatment is associated with reaccumulation of amyloid PET and plasma and CSF biomarkers, and reversion to placebo rate of clinical decline.
According to a press release from the manufacturer, lecanemab-irmb works to fight AD in 2 ways: continuously clearing protofibrils and rapidly clearing highly toxic protofibrils, which can continue to cause neuronal injury even after the amyloid-beta plaque has been cleared from the brain.
Ongoing treatment can slow disease progression and prolong the benefit of therapy with the goal of helping patients maintain their sense of self for longer periods of time.
Reference
Biogen. FDA approves LEQEMBI (lecanemab-irmb) IV maintenance dosing for the treatment of early Alzheimer’s disease [press release]. Published January 26, 2025. Accessed January 31, 2025. https://investors.biogen.com/news-releases/news-release-details/fda-approves-leqembir-lecanemab-irmb-iv-maintenance-dosing