In an unexpected move, the FDA has decided to hold an advisory meeting of outside experts to discuss the efficacy and safety of donanemab for Alzheimer's disease.
Instead, the FDA will convene a meeting of outside experts to discuss the phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab in early symptomatic AD.
"It was unexpected to learn the FDA will convene an advisory committee at this stage in the review process, but we look forward to the opportunity to further present the TRAILBLAZER-ALZ 2 results and put donanemab's strong efficacy in the context of safety," Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience, said in a statement.
The TRAILBLAZER-ALZ 2 study showed that donanemab significantly slowed cognitive and functional decline in patients with early, symptomatic AD in comparison with placebo.
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