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Dissecting FDA’s aducanumab decision: a BioCentury podcast

BioCentury’s editors weigh the pros and cons of the accelerated approval

BioCentury’s editors weigh the pros and cons of the accelerated approval.

June 8, 2021 1:43 AM UTC

Has FDA made the correct decision in approving Biogen’s aducanumab for Alzheimer’s disease? On the latest BioCentury This Week podcast, BioCentury’s editors break down the impact of the agency granting accelerated approval to the anti-β-amyloid drug, including the new surrogate endpoint for the decision, the potential for eroded trust in FDA, and what’s next in the pipeline. They also preview BioCentury’s upcoming China Healthcare Summit.

Executive Editor Selina Koch expresses surprise that FDA chose to approve the drug via the accelerated approval pathway.

“I had assumed, and apparently incorrectly, that in order to use a biomarker as a surrogate endpoint, FDA would want to have seen in the past a demonstration that that biomarker and clinical benefit correlate with each other. And that has not been demonstrated for amyloid,” Koch says.

“This is a very marginal therapy. The amount of benefit, if you believe there is benefit, is right up on the threshold of clinical meaningfulness,” she says. “Patients will get worse over time. There’s no way to know if they would have been even worse without it, there just won’t be.”

As a result, Koch argues, use of the drug may diminish over time because it is a “burdensome” therapy that is “not cheap.”

She adds FDA’s accelerated approval of aducanumab marks the acceptance of β-amyloid as a surrogate endpoint for Alzheimer’s disease.

Washington Editor Steve Usdin questions what happened to change FDA’s mind about accelerated approval, given that at a November advisory committee to discuss the therapy FDA said the pathway was not on the table.

And while he doesn’t believe the approval will set a precedent across FDA, he does think the agency has weakened the bonds of trust that are its greatest strength.

Editor in Chief Simone Fishburn sees an upside in FDA’s statement that it expects to see increased use of accelerated approval for neurodegenerative diseases.

“I really think that something like more use of accelerated approval in that field is probably a good thing. Does that mean I think this is a great decision? No, I don’t. But if it ushers in an era of new therapies where — I’m going to assume we’re going to be talking about therapies that do no harm, that’s also part of the equation— there really is a lot of need, I think we have to be sensitive to that.” she said. 

Executive Editor Jeff Cranmer points to the announcement’s impact on biotech stocks, which rose broadly on Monday. In addition to Biogen, big winners included Eli Lilly and Co. (NYSE:LLY), whose shares rose $20.50 (10%) to $222.52 for a gain of $19.6 billion in market cap, and AC Immune S.A. (NASDAQ:ACIU), whose stock rose 28% to bring its market cap to about $583 million.

Josh Berlin, BioCentury’s executive director of BD and a member of the China Summit Organizing Committee, previews the upcoming BioCentury-BayHelix China Healthcare Summit, which will take place Nov. 16-19, as a hybrid event, with a venue in Shanghai for those able to attend in person.

This year’s theme is “time to deliver,” says Berlin, adding that panelists selected by BioCentury, BayHelix and McKinsey & Co. will explore the question “What are China biotechs creating with all the money raised, and when will patients and investors get their ROI now that we actually have crossed the Bridge to Innovation?”

More than 50 companies from around the world will be selected to present. Registration opens this week at