Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD), the population in which treatment was initiated in clinical trials.
LEQEMBI selectively binds to soluble A aggregates (protofibrils), as well as insoluble A aggregates (fibrils) which are a major component of A plaques, thereby reducing both A protofibrils and A plaques in the brain. LEQEMBI is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. LEQEMBI has also been approved in the
LEQEMBI's approval is based on the large global Phase 3 Clarity AD study. In the Clarity AD study, LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results.
Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of A, having a primary role in the cognitive decline associated with this progressive, debilitating condition.3 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble A plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.4
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About lecanemab (LEQEMBI)
Lecanemab is the result of a strategic research alliance between
LEQEMBI's FDA approval was based on Phase 3 data from
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