Subjects ” Alzheimer’s and dementia
The Food and Drug Administration (FDA) has granted Breakthrough Therapy status to Lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody for the treatment of Alzheimer’s disease.
The designation is based on data from a randomized, double-blind phase 2b proof-of-concept study (ClinicalTrials.gov Identifier: NCT01767311) in which lecanemab was used in 856 patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease confirmed presence of amyloid pathology. A pre-set analysis showed that lecanemab at the highest doses showed consistent reductions in clinical decline across multiple clinical endpoints and biomarker endpoints.
Lecanemab is currently being investigated in the Phase 3 Clarity AD study (ClinicalTrials.gov Identifier: NCT03887455) in 1,795 patients with early-stage Alzheimer’s disease; the study was recruited in March 2021. Lecanemab is also being used in the Phase 3 AHEAD 3-45 study (ClinicalTrials.gov Identifier: NCT04468659) in people with preclinical Alzheimer’s disease, defined as clinically normal patients with intermediate or elevated levels of amyloid in the brain.
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reference
Eisai and Biogen Inc. announce that the US FDA has granted Breakthrough Therapy status to Lecanemab (BAN2401), an anti-amyloid beta protofibril antibody for the treatment of Alzheimer’s disease. [press release]. Tokyo, Japan and Cambridge, MA: Eisai Co., Ltd. and Biogen Inc .; June 23, 2021.
This article originally appeared on MPR
Subjects:
Treatment of Alzheimer’s disease and dementia for cognitive impairment
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