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FDA Approves Controversial Drug-Slowing Alzheimer’s Progression

On January 6 of this year, the FDA approved the biologic drug lecanemab for the treatment of Alzheimer’s disease through an accelerated process. Although the results of their clinical studies indicate a delay in disease progression in patients who received it, the risk of adverse events and the high cost of the drug appear to outweigh the benefits.

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The results of the phase III study in which more than 1,000 people diagnosed with the disease participated concluded in a decrease in the amyloid markers characteristic of the pathology in the group that received the asset, this was accompanied by a moderate decrease in the progression evaluated in cognitive abilities and function compared to the group that received placebo. However, the authors report that these findings have been accompanied by adverse events, as well as concluding the need for longer studies to determine the efficacy and safety of the biologic.

Among the adverse events observed are inflammation and bleeding of the brain, so the FDA, with approval, issues an alert label suggesting three nuclear MRIs during the first six months of treatment as medical surveillance measures, as well as a contraindication of anticoagulants.

On the other hand, the cost of the drug, without considering the MRIs and expenses associated with intravenous infusion (the route by which it must be administered), is estimated at about $ 25,000 per year.

While the approval of the drug represents an alternative for the treatment of people living with Alzheimer’s, which could translate into more and better quality time, the accelerated approval process in the face of worrying safety evidence should probably not be considered.

Dr. Carmen de la Rocha

Director of Research and Development at Drox Health Science. PhD in Biotechnology, Master in Biochemical Engineering. Member of the National System of Researchers level I.

Sources

van Dyck, C. H., et al (2023). Lecanemab in Early Alzheimer’s Disease. TheNewEnglandjournal ofmedicine 388(1), 9–21. Available at: https://doi.org/10.1056/NEJMoa2212948

FDA approves new antibody to slow alzheimer’s disease, even as safety concerns linger (6 Jan, 2023) Science (Accessed: January 10, 2023). Available at: https://www.science.org/content/article/ fda-approves-new-antibody-slow-alzheimer-s-disease-even-safety-concerns-linger

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