A sign identifies a Biogen facility in Cambridge, Massachusetts, March 9, 2020.
Brian Snyder | Reuters
Biogenic Shares fell Friday after the chief of the Food and Drug Administration called for an investigation into the company’s recent approval of the company’s Alzheimer’s drug Aduhelm.
In a letter dated and published Friday, Acting FDA Commissioner Dr. Janet Woodcock asked the independent inspector general’s office to investigate interactions between the US agency and Biogen officials prior to the drug’s approval on June 7th.
“I believe it is critical that the disputed events be reviewed by an independent body such as the Office of the Inspector General to determine whether any interactions between Biogen and the FDA investigators were inconsistent with FDA policies and procedures.” Woodcock wrote.
Biogen shares fell more than 3% after the announcement.
Biogen’s stock rose last month after the FDA issued the Drug from the biotech company, the first US government-approved drug to slow cognitive decline in people with Alzheimer’s disease, and the first new drug for the disease in nearly two decades.
This decision was a departure from the recommendations of the agency’s independent panel of external experts, who unexpectedly refused to support the drug last fall, citing unconvincing data. At least three members of the committee resigned in protest after the agency’s approval.
Federal agencies have faced heavy pressure from friends and family of Alzheimer’s patients to ask for the drug scientifically known as aducanumab to be expedited. STAT News and other media reported by FDA officials used an official abbreviation Get approval to get the drug to market faster.
This is a developing story. Please check again for updates.