The drugmaker had initially expected approval by the beginning of 2024, but the FDA denied an accelerated approval and delayed the advisory committee meeting. During a seven-hour meeting on June 10, the committee heard from Eli Lilly executives, FDA clinical safety reviewers and the general public about the therapy that slowed cognitive and functional decline by 60% in a phase 3 trial.
After the committee members discussed the findings and presentations, they unanimously agreed that donanemab is effective for people with mild cognitive impairment and mild dementia and that the benefits outweigh the risks.
The FDA is expected to make its final decision on donanemab by the end of 2024.
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