Just days ago, success in Eli Lilly’s 30-year pursuit of an Alzheimer’s disease drug seemed all but guaranteed. Now, the FDA’s eleventh-hour decision to convene a committee of independent experts could delay a ruling on donanemab for months.
According to Lilly, regulators are especially interested in discussing the drug’s safety, the company’s decision to stop treatment once it clears up amyloid plaques, and analyses that suggest levels of the brain protein tau can predict how well a person responds to treatment.
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