The U.S. Food and Drug Administration (FDA) has granted traditional approval to the Alzheimer's drug Leqembi (lecanemab-irmb). This decision follows a confirming trial that established its clinical benefits. Leqembi is the first antibody targeting amyloid beta to transition from accelerated approval to traditional approval for Alzheimer's treatment. The drug's mechanism involves reducing the amyloid plaques characteristic of the disease in the brain.
Originally approved through the Accelerated Approval pathway in January, Leqembi's effectiveness in reducing brain amyloid plaques—a key pathological aspect of Alzheimer's—led to its traditional approval. Accelerated Approval permits the FDA to sanction drugs for serious conditions with limited treatment options, based on surrogate endpoint data that predicts clinical advantages. A subsequent confirmatory trial, Study 301 (CLARITY AD), was mandated as part of the postmarketing requirements for Leqembi's accelerated approval.
Alzheimer's, a progressive and irreversible brain disorder, impacts over 6.5 million Americans by eroding memory, cognitive functions, and daily tasks. While its precise causes remain uncertain, the disease manifests in brain changes involving amyloid beta plaques and tau tangles, resulting in neuron and connection loss.
Study 301 enrolled 1,795 Alzheimer's patients in a randomized, double-blind, placebo-controlled trial. Leqembi was administered to those with mild cognitive impairment or early-stage dementia and confirmed amyloid beta pathology. The trial demonstrated significant reduction in decline over 18 months on the primary outcome measure.
Leqembi's application is recommended for individuals with mild cognitive impairment or early-stage dementia. The drug's effectiveness at other disease stages has not been established.
The FDA's traditional approval of Leqembi is a significant stride in Alzheimer's research. By targeting amyloid beta plaques, the drug presents hope for managing this devastating disease, potentially improving the lives of millions. This milestone reinforces the continuous pursuit of effective treatments, offering a glimpse of victory in humanity's battle against Alzheimer's.
Source: FDA News Release. "FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval". https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval. July 06, 2023. [Accessed: July 08 2023].
Edited by Arnav Dhavale.
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