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Advisory Panel of Experts Endorses FDA Approval of New Alzheimer's Drug

An anonymous reader quotes a report from the New York Times: A committee of independent advisers to the Food and Drug Administration voted unanimously on Monday that the benefits outweigh the risks of the newest experimental drug for Alzheimer's disease. Alzheimer's afflicts more than six million Am...

It modestly slowed cognitive decline in patients in the early stages of the disease but also had significant safety risks, including swelling and bleeding in the brain. The drug is based on a long-held hypothesis that Alzheimer's disease begins when rough hard balls of amyloid, a protein, pile up in patients' brains, followed by a cascade of reactions leading to the death of neurons. At issue before the committee on Monday were some unusual aspects of donanemab's clinical trials, especially that study participants stopped taking the drug as soon as their amyloid was cleared.

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