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Lecanemab (a.k.a. leqembi) has received full approval from the U.S. Food and Drug Administration. This is the first FDA-approved treatment to help slow the progression of Alzheimer’s disease.
In early 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new Alzheimer’s drug called Leqembi. (Biogen, a biotechnology company, and Eisai, a pharmaceutical ...
[10] [11] [12] The FDA stated that it represents a first-of-its-kind treatment approved for Alzheimer's disease and that it is the first new treatment approved for Alzheimer's since 2003. [3] Aducanumab's approval is controversial for numerous reasons including ambiguous clinical trial results regarding efficacy , the high cost of the ...
The FDA granted accelerated approval to aducanumab for the treatment of Alzheimer’s disease in 2021 based on its ability to clear amyloid plaques. While aducanumab was successful in clearing ...
[13] [14] [15] The FDA stated that it represents a first-of-its-kind treatment approved for Alzheimer's disease and that it is the first new treatment approved for Alzheimer's since 2003. [6] Aducanumab's approval is controversial for numerous reasons including ambiguous clinical trial results regarding efficacy , the high cost of the ...
The agency’s approval was based on a late-stage clinical trial of 1,700 people that showed the drug slowed the progression of Alzheimer’s by about 35% after 18 months, compared to a placebo ...
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