STAT Plus: Biogen delays Alzheimer’s drug filing to FDA, citing Covid-19, complexity of data analysis
Biogen said Wednesday that the submission of a U.S. marketing application for its Alzheimer’s drug aducanumab has been delayed until the summer.
The Cambridge, Mass.-based biotech had said previously the drug would be filed with the Food and Drug Administration in “early 2020.” The submission will now occur in the third quarter, following a scheduled meeting with FDA staff, Biogen said.
