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Top Alzheimer’s scientists still divided about approving contentious drug

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The FDA is being asked to either approve the therapy based on what numerous scientists say is an inconclusive record, or force Biogen to carry out another costly trial that could take years

A Biogen facility in Cambridge, the US. Picture: REUTERS/BRIAN SNYDER

Choosing a course of action is shaping up as one of the most consequential drug-approval decisions that the FDA has made in years. Biogen has said it plans to submit aducanumab to the agency in early 2020. At stake are the fates millions of Alzheimer’s patients, along with billions of dollars in sales and stock-price gains for Biogen and its Japanese partner Eisai.

“They need a tiebreaker,” said Suzanne Craft, an Alzheimer’s researcher at Wake Forest School of Medicine, shortly after the presentation, expressing a widely held sentiment among the attendees. “We all want it to be real, but the evidence is not sufficient to justify declaring this a ready-for-prime-time treatment.

“While we’d love to see a drug benefit millions of people, this remains a subgroup analysis of post-hoc data,” he wrote. “In a normal world, this isn’t sufficient for approval.”

 

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