Lilly’s donanemab fails to get early FDA approval for Alzheimer’s
The FDA argues that not enough patients in a Lilly trial stayed on the company’s Alzheimer’s medicine for long enough to warrant accelerated approval.
By Robert Langreth and Nacha Cattan, bloomberg
Eli Lilly & Co.’s bid for accelerated approval of its Alzheimer’s therapy donanemab was rejected by US regulators, an unexpected setback for the drugmaker.
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