FDA squashes accelerated hopes for Eli Lilly’s Alzheimer’s drug as agency asks for more data
The FDA flashed a red light on Eli Lilly’s investigational Alzheimer’s drug donanemab, spurning hopes of two new medications for the disease this month.
The Big Pharma put out word after the markets closed Thursday saying the US regulator denied the accelerated approval “based on limited number of patients with 12-month drug exposure data” in the submission. Patients in the trial were allowed to wean off treatment once a certain amount of amyloid protein was cleared from their brains, meaning some patients did not receive the study drug for 12 months. “No other deficiencies were identified,” Lilly said in a statement.
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