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30 Nov | 2022

A new research drug against Alzheimer's confirms its positive results during CTAD

The pharmaceutical companies Biogen and Eisai have presented during the Congress of Clinical Trials on Alzheimer's (CTAD), held in San Francisco, the results of the phase III study of their drug lecanemab. The article, published in The New England Journal of Medicine, confirms the data that the laboratories had advanced in September of this year: lecanemab reduces amyloid markers and has managed to slow cognitive deterioration by 27% in patients in early stages of Alzheimer's. It is therefore the first drug that would manage to modify the course of the disease, slowing cognitive deterioration, which is why it represents a significant advance in Alzheimer's research.

The results are positive, and longer studies are needed to determine the long-term effect of the drug (so far, the trial has investigated the impact of the drug over 18 months of administration). In addition, further research is needed to determine exactly what its clinical relevance may be, which patients could benefit from it, and also to continue studying its safety profile. The study presented in San Francisco by Biogen and Eisai has also confirmed some adverse effects of the drug (it has been associated with a type of brain inflammation in 12.6% of patients) which, despite not being serious effects, must be be studied in more detail.

According to the pharmaceutical laboratories, the American regulatory agency FDA (Food & Drug Administration) could approve the drug in a few months. The companies will also request the approval of the European regulatory agency (EMA- European Medicines Agency) during the first quarter of 2023.

Lecanemab is an antibody that selectively binds to beta-amyloid protofibrils and is under investigation for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease, with confirmed presence of amyloid pathology in the brain.