FDA advisors unanimously agree that the benefits of donanemab for Alzheimer's patients outweigh the risks. The drug, though modestly effective, also poses significant safety risks such as brain swelling and bleeding.
The drug is based on the theory that Alzheimer's originates from the accumulation of amyloid protein in the brain, leading to neuron death. Donanemab aims to clear amyloid and slow cognitive decline in early-stage patients.
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