FDA requires federal investigation into approval

Biogen 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.

Acting FDA commissioner Dr. Janet Woodcock asked the Office of the Inspector General 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 if any interactions between Biogen and the FDA investigator staff were inconsistent with FDA policies and procedures.” wrote in a letter sent on Friday.

Biogen shares fell more than 3% after the announcement.

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

This decision was a departure from the recommendations of the agency’s independent panel of external experts, which unexpectedly refused to approve the drug last fall, citing inconclusive 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 outlets reported that FDA officials used a government abbreviation to get approval to bring the drug to market earlier.

Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid that scientists expect to play a role in the devastating disease.

It is rare for an FDA chief to request an investigation into the agency’s own decisions. It is the most recent setback for the company and the drug, which has been controversial since its promising development in 2016.

In March 2019, Biogen withdrew from development of the drug after analysis by an independent group found it was unlikely to work. A few months later, the company shocked investors when it announced that it would still have government approval for the drug.

When Biogen filed for approval for the drug in late 2019, its scientists said a new analysis of a larger dataset showed that aducanumab “reduces clinical decline in patients with early-stage Alzheimer’s”.

Alzheimer’s experts and Wall Street analysts were immediately skeptical, wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it difficult for other companies to enroll patients in their own drug trials.

Some doctors have said they won’t prescribe aducanumab because of the mixed data package that supports the company’s application.

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