USFDA nod to Leqembi IV maintenance dosing for treatment of early Alzheimer's Disease: Eisai, Biogen
Tokyo: Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four weeks lecanemab-irmb (U.S. brand name: LEQEMBI) intravenous (IV) maintenance dosing.
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) in the U.S. After 18 months of once every two weeks initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two 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. 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. AD is a progressive, relentless disease caused by a continuous underlying neurotoxic process that begins before and continues after plaque removal. Only LEQEMBI works to fight AD in two ways: continuously clearing protofibrils and rapidly clearing plaque. This is important because with continuous administration, LEQEMBI clears highly toxic protofibrils* which can continue to cause neuronal injury even after the amyloid-beta (Aβ) plaque has been cleared from the brain. Importance of Ongoing Treatment
• Data from the off-treatment period between the Study 201 (Phase 2) 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.
• For maintenance treatment, once every four weeks dosing regimen may be easier than once every two weeks dosing for patients and care partners to continue treatment for early AD.
• Ongoing treatment can slow disease progression and prolong the benefit of therapy, with the goal of helping patients maintain who they are for longer.
• In the Clarity AD core study (18 months), the mean change from baseline between the once every two weeks lecanemab treated group and the placebo group was -0.45 (P<0.0001) on the primary endpoint of the Clinical Dementia Rating-Sum of Boxes (CDR-SB) global cognitive and functional scale.
• Over three years of treatment across the Clarity AD core study and LTE, LEQEMBI reducedcognitive decline on the CDR-SB by -0.95 relative to a matched natural history cohort - showing clinically meaningful benefit for early AD patients.
o A change from 0.5 to 1 on the CDR score domains of Memory, Community Affairs and Home/Hobbies is the difference between slight impairment and loss of independence, such as people's ability to be left alone, remember recent events, participate in daily activities, complete household chores, function independently and engage in hobbies and intellectual interests
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