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FDA Gives Accelerated Approval for Risky Alzheimer’s Pill

FDA Gives Accelerated Approval for Risky Alzheimer’s Pill
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From Joseph Mercola, DO

The U.S. Food and Drug Administration granted accelerated approval for the Alzheimer’s disease drug lecanemab (Leqembi). The drug, a monoclonal antibody, binds to amyloid beta in the brain.

An 18-month study published in the New England Journal of Medicine found Leqembi reduced markers of amyloid in early Alzheimer’s disease and led to “moderately less decline” in cognition and function compared to placebo. However, the study added, the drug was “associated with adverse events.”

The FDA granted accelerated approval of Leqembi based on the observed reduction of amyloid beta plaque. The study involved 856 patients with Alzheimer’s disease, with drug treatment started at the point of mild cognitive impairment or mild dementia, along with the confirmed presence of amyloid beta. According to the FDA:

“Patients receiving the treatment had significant dose- and time-dependent reduction of amyloid beta plaque, with patients receiving the approved dose of lecanemab, 10 milligram/kilogram every two weeks, having a statistically significant reduction in brain amyloid plaque from baseline to Week 79 compared to the placebo arm, which had no reduction of amyloid beta plaque.”

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