An advisory committee to the Food and Drug Administration found the drug was safe and effective at slowing the progression of the disease, setting the stage for the agency to approve it.
An advisory committee to the Food and Drug Administration on Monday endorsed an Alzheimer’s drug made by Eli Lilly, setting the stage for the agency to approve another medication that has shown it can slow the progression of the disease.
“I do believe we need to think responsibly if this medicine is going to come to market, because there are risks associated,” said Sarah Dean, the panel’s consumer representative. Eli Lilly shares rose 1.8 percent Monday, as panel members voted. Still, donanemab is unlikely to be an instant blockbuster, according to Wall Street analysts. David Risinger, an analyst at Leerink Partners, said in a research note Sunday that the drug has a “questionable competitive profile.”A key feature of Eli Lilly’s approach is that treatment with the drug could be discontinued once a patient’s amyloid levels are reduced to a certain level.
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