Eisai’s Leqembi wins accelerated U.S. approval and unlocks broader Medicare coverage for the drug

1. Leqembi reduced amyloid markers in early Alzheimer’s disease and resulted in moderately less decline in measures of cognition and function compared to placebo.
2. Adverse events of Leqembi included amyloid-related imaging abnormalities (ARIA) and infusion reactions.

The Latest

A phase 3 clinical trial funded by Eisai and Biogen investigated the effects of Leqembi in patients with early Alzheimer’s disease. The results indicated that Leqembi significantly reduced amyloid markers in early Alzheimer’s disease and slowed the progression of cognitive and functional decline over 18 months. Leqembi is an exciting pharmacological discovery because, unlike other Alzheimer’s interventions focusing on symptomatic treatment, Leqembi can directly slow disease progression. In some countries, Leqembi could potentially be the first new drug approved for Alzheimer’s disease in 20 years.

Physician’s Perspective

Dementia is a term to describe several diseases that affect memory, thinking, and the ability to perform daily activities. Alzheimer’s disease is the most common form of dementia and may contribute to 60-70% of cases. According to the WHO, currently, more than 55 million people have dementia worldwide and there are nearly 10 million new cases every year. In clinical trials, Leqembi resulted in a 28% slower cognitive decline than placebo. This would mean that patients and families could see another four to five additional months of retained function. Patients and physicians should be aware a big exclusion criterion for Leqembi is being on blood thinner medications or being too far progressed in the disease. Too far progressed in the disease is defined as patients who are dependent on others for daily needs such as getting dressed.

Molecular Target of Therapy

The build-up of amyloid beta plaques in the brain is a major pathophysiological feature of Alzheimer’s disease. Beta-amyloid plaques are small pieces or groups of protein that clump together to block cell-to-cell signaling at synapses and activate immune system cells, triggering inflammation. Leqembi is a humanized monoclonal antibody that binds to soluble amyloid-beta protofibrils. By binding and neutralizing the amyloid-beta plaques, Leqeumbi is potentially able to slow disease progression.

Company History

Leqembi is the result of a collaborative research partnership between Eisai and BioActic. The primary objective of the collaboration was to uncover an immunotherapy solution for Alzheimer’s disease with a research focus on the Arctic mutation of amyloid beta-peptide. Beyond, Alzheimer’s Disease, Eisai’s research and development pipeline includes other medications in neurology, oncology, and gastrointestinal disorders.

Further reading: https://www.nejm.org/doi/full/10.1056/NEJMoa2212948

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