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Aducanumab Fall-Out: An Inexpedient Use Of ‘Expedited’ Review

 
• By Michael McCaughan

The aducanumab review involved everything sponsors might think they could want from the US FDA, with the agency taking a hands on approach to expedite a complex and difficult review in hopes of delivering an important new therapy to patients as quickly as possible. Unfortunately, in this case, FDA seems to have expedited the review right over a cliff.

Express delivery van jumps over cliff
The US FDA chose the most direct route to deliver the Biogen Alzheimer’s candidate to market, but it might not make it. • Source: Shutterstock

When Biogen, Inc. first approached the US Food & Drug Administration with the surprising news that an Alzheimer’s study that had been halted for “futility” actually appeared to show efficacy, the “simple” answer would have been to ask for a new trial to confirm the finding.

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