Eli Lilly’s Alzheimer’s drug donanemab edged closer to US regulatory approval on Monday, after a panel of independent scientific experts concluded the benefits of the experimental treatment outweighed the risks.
The advisory committee of 11 independent experts convened by the US Food and Administration voted unanimously that donanemab was an “effective” treatment for Alzheimer’s.
But they cautioned more data was needed to understand its effects in patients with low or no levels of tau, a protein linked to Alzheimer’s, because Eli Lilly excluded them from the clinical trial.
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