FDA Requests Probe Into Staff Interactions With Biogen Ahead Of Aduhelm Approval

Biogen Inc. (NASDAQ: BIIB) shares came under pressure Friday after the Food and Drug Administration called for an investigation into the approval of the company's Alzheimer's treatment Aduhelm.

What Happened: In a letter disclosed publicly, FDA Acting Commissioner Janet Woodcock requested the office of the inspector general at the Department of Health and Human Services review and assess the interactions between representatives of Biogen and the FDA in the run up to the approval of the biologic license application for Aduhelm.

The inspector general's office was also asked to determine whether any of these interactions were inconsistent with FDA policies and procedures.

The FDA commissioner attributed the move to concerns raised regarding contacts between FDA staffers and Biogen executives during the review process, including those that may have occurred outside of the formal correspondence process.

It is critical the events be reviewed by an independent body given the concerns could undermine the public's confidence, Woodcock said in the letter.

Woodcock also promised full cooperation should the office undertake a review and expressed a willingness to address the issues if the review results in actionable items.

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Why It's Important: After nearly shelving Aduhelm following not-so-promising late-stage results, Biogen resurrected it following a subset analysis of data.

After an Adcom review that did not view the treatment as promising and a three-month extension of the review period, the FDA  approved the drug. The regulator did require a post-approval confirmatory trial.

The broad label the FDA accorded to Aduhelm and the exorbitant pricing did not go down well with many in the scientific community and lawmakers.

Buckling under pressure, FDA narrowed the Aduhelm label Thursday to recommend usage of treatment for mild Alzheimer's disease.

BIIB Price Action: At last check, Biogen shares were down 3.01% at $357.96 at last check Friday.

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