The FDA reviews Eli Lilly's experimental Alzheimer's drug, donanemab, for potential risks and benefits.

The US FDA is reviewing Eli Lilly's experimental Alzheimer's drug, donanemab, which aims to remove toxic beta-amyloid plaques from the brains of people with early-stage Alzheimer's disease. The FDA will determine if the treatment's benefits outweigh its risks, as donanemab showed a 29% slowing in memory and thinking problems in a large clinical trial, but brain swelling and bleeding were more common in trial participants. If approved, a prescribing label for the drug will likely highlight risks and strategies to mitigate them, and post-approval requirements may include expedited reporting of any deaths in ongoing studies.

June 06, 2024
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