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Why the FDA didn't grant an approval to Lilly's Alzheimer's drug

Por: MarketWatch Business January 20, 2023

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Why the FDA made its decision The FDA told the drugmaker that it wanted to see clinical data from at least 100 patients with early symptomatic Alzheimer’s disease who had taken donanemab for a year. Lilly said that “many patients” included in the Phase 2 clinical trial stopped treatment as early as six months due to the “speed of plaque reduction.” No other issues were cited in the FDA’s complete response letter. The fuller data set... + full article



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