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‘Embarrassing About-Face’: FDA’s Aduhelm Labeling Change Does Little To Improve Frustration Over Alzheimer’s Approval

Executive Summary

US FDA’s update to Biogen’s Aduhelm label was the right move, drug policy experts say, but that doesn’t mean the agency should expect a round of applause. Instead, they expect it will only heighten the controversy and tension over the unexpected June accelerated approval of the pricey new Alzheimer’s disease drug and could further erode trust in the agency. The updated indication, which emphasizes initiating treatment in patients with mild disease, still gives plenty of wiggle room for wider prescribing.

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Biogen’s Plea To Medicare: Just Cover The Aduhelm Clinical Trial Population

Company discusses its strategy for negotiating a change in the recently-proposed Medicare coverage decision for Alzheimer’s drugs during a presentation to analysts.

Aduhelm Price Cut May Help Pave The Way For Medicare National Coverage Determination

With CMS draft decision expected next month on amyloid-clearing antibodies for Alzheimer’s, Biogen slashes Aduhem’s price 50% to $28,200 per year. Move reverses another aspect of the approval that drew criticism, including the expansive label and long horizon for confirmatory data.

And Then There Were Three: Woodcock Offers Another Explanation For Aduhelm’s Labeling Fiasco

Acting US FDA Commissioner says it is standard for the Office of Neuroscience to issue broad labels like the one originally granted to Biogen’s new Alzheimer’s drug, but the agency declined to answer follow-up questions on such a policy. Woodcock continued to defend Aduhelm’s accelerated approval but conceded that the process might have been improved in an unusually tense public appearance.

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