The Food and Drug Administration has rejected an experimental Alzheimer’s disease drug being developed by Eli Lilly, denying an attempt by the Indianapolis-based pharmaceutical company to secure accelerated approval for the medicine.
In issuing a so-called complete response letter, the FDA requested Lilly provide data from more patients who had taken the company’s drug, known as donanemab, for longer than one year. The regulator did not cite any other reasons in its decision, the company said in a Thursday evening statement announcing the rejection.
