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FDA calls for federal probe into approval

Sign of a Biogen facility on March 9, 2020 in Cambridge, Massachusetts.

Brian Snyder | Reuters

Shares of Biogen 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, EduHelm.

In a letter released and made public Friday, Acting FDA Commissioner Dr. Janet Woodcock asked the independent office of the inspector general to investigate conversations between the US agency and Biogen representatives ahead of the drug’s approval on June 7.

“I believe it is important that the incidents of the issue be reviewed by an independent body such as the Office of the Inspector General to determine whether any interactions that took place between Biogen and the FDA review staff are based on FDA policies and procedures. was inconsistent with or not.” Woodcock wrote.

Biogen shares fell more than 3% following the announcement.

Biogen’s stock soared last month after the FDA approved the biotech company’s drug, the first drug approved by US regulators to slow cognitive decline in people living with Alzheimer’s and the disease in nearly two decades. The first new drug for

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That decision marked a departure from the advice of the agency’s independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At least three members of the panel have resigned in protest following the agency’s approval.

Federal regulators faced intense pressure from friends and family members of Alzheimer’s patients, asking them to fast-track the drug, scientifically known as aducanumab. State news and other media outlets reported that FDA officials used a regulatory shortcut to gain approval to bring the drug to market as quickly as possible.

This is a developing story. Please check back for updates.

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