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FDA acting commissioner Janet Woodcock requests independent review of Aduhelm approval

Approval of Biogen's Alzheimer's disease treatment has raised concerns over FDA staff interactions with the company

The US Food and Drug Administration’s (FDA) acting commissioner Janet Woodcock (pictured above) has called for an independent review into the agency’s approval of Biogen’s Alzheimer’s disease (AD) treatment Aduhelm.

The FDA initially approved Aduhelm (aducanumab) for all AD patients in June, despite clinical trials only evaluating the anti-amyloid antibody in patients with milder forms of the disease.

Since then, the FDA has narrowed the label for Aduhelm to only include AD patients with mild cognitive impairment or mild dementia following criticism from experts in the field.

Now, Woodcock wants the process for review of Biogen’s biologics licence application (BLA) for Aduhelm to be looked at again, including an ‘ongoing focus on interactions’ between Biogen and FDA staff during the review process.

The aim of the independent review will be to determine if any of those interactions were inconsistent with FDA policies and procedures.

The call for an independent review comes after concerns were raised regarding contact between Biogen representatives and the FDA during Aduhelm’s review process, including some that ‘may have occurred outside the formal correspondence process’.

In a letter addressed to the US Department of Health and Human Services’ (HHS) acting inspector Christi Grimm, Woodcock wrote: 'To the extent these concerns could undermine the public’s confidence in FDA’s decision, I believe it is critical that the events at issue be reviewed by an independent body.'

Aduhelm’s approval has been met with continued criticism, particularly as an independent advisory panel had voted against approval of the drug last year.

Since Aduhelm's approval, three members of that panel have resigned, including Aaron Kesselheim, a professor of medicine at Harvard Medical School, who said the authorisation “was probably the worst drug approval decision in recent US history”.

In response to Woodcock’s request for an independent review, Kesselheim told the New York Times that “it’s really important that an investigation happen publicly and quickly so that we find answers to some of the many outstanding questions swirling around this decision”.

The FDA granted Aduhelm an accelerated approval, meaning that a confirmatory study is needed to ensure the drug can continue to be used to treat certain Alzheimer’s disease patients.

Article by
Lucy Parsons

12th July 2021

From: Regulatory



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