A sign marks a Biogen facility, in Cambridge, Massachusetts, March 9, 2020.
Brian Snyder | Reuters
Biogen shares fell on Friday after the head of the Food and Drug Administration called for an investigation into the recent approval of the company’s Alzheimer’s drug, Aduhelm.
In a letter dated and made public Friday, Acting FDA Commissioner Dr. Janet Woodcock asked the independent Office of the Inspector General to investigate how the U.S. agency interacted with Biogen representatives before the company’s drug was approved on June 7.
“I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General in order to determine whether any interactions that occurred between biogen and FDA review staff were inconsistent with FDA policite and procedures,” Woodcock wrote.
Shares of Biogen were down more than 3% after the announcement.
This is a developing story. Please check back for updates.