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FDA Approves Lecanemab for the Alzheimer’s in USA

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FDA Approves Lecanemab for the Alzheimer’s in USA

The FDA has granted approval to the Alzheimer's medication Lecanemab.

Dr.P.Harinath by Dr.P.Harinath
July 16, 2023
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The FDA has granted approval to the Alzheimer’s medication Lecanemab.

Lecanemab is antibody, which targets the protein beta-amyloid, can now be utilized in the United States for individuals with early-stage Alzheimer’s.

The approval is based on the findings of a Phase III study that clearly demonstrated the medication’s positive impact on cognition scores. Lecanemab was found to slow down the progressive decline in cognitive function by 27% over the course of the study, while also effectively reducing amyloid deposits in the brain, directly intervening in a key pathological process of the disease.

slow down the progressive decline in cognitive function by 27%

The medical community already considers this drug a “landmark in Alzheimer’s research.” However, there is an ongoing debate about whether the extent of cognitive decline reduction justifies the use of a medication that costs nearly $26,000 per year. The FDA’s announcement also highlights the potential for severe side effects associated with amyloid-targeted medications, including brain swelling and bleeding.

The approval and availability of this medication in the EU have yet to be determined.

Source: FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval | FDA
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