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FDA Gives Accelerated Approval for Risky Alzheimer’s Pill

FDA Gives Accelerated Approval for Risky Alzheimer’s Pill

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.”

Read the full article.

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3 thoughts on “FDA Gives Accelerated Approval for Risky Alzheimer’s Pill

  • S

    There are soooooo many safe supplements to assist people with brain issues that aren’t medications. Research them with your orthomolecular specialist or functional medical doctor. I would never trust a drug similar to Aricept, which never worked at all for most people. The last drug for Alz that was marketed in the past couple of years wasn’t even recommended by FDA employees.

  • Jonathan Schult

    This is just what I’ve been trying to convince my local legislators to follow up. The FDA is an APPOINTED group, not voted in, and as such have TOO MUCH POWER to regulate too many things they have no knowledge of, and should have no bearing over. They are forever in Big Pharma’s pocket, and have gotten rich by approving drugs that KILL. I for one am sick and tired of this group making the wrong decisions for me, and the right ones for Big Pharma. Their days of approving the wrong drugs while trying to prohibit supplements that can help me should be OVER.

    Dismantle this group, and replace it with one that the people of the USA VOTE IN every four years. It’s a notion whose time has come.

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