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2021-06-23 17:00:04

Ultimately, top officials decided that the evidence indicating that the drug worked, while inconclusive, was strong enough to allow doctors and patients to decide for themselves whether to take it, according to the memos. “FDA, then, is faced with a situation where the available evidence on the clinical endpoints is short of what we would require for standard approval of aducanumab,” wrote Peter Stein, director of the FDA’s office of new drugs, in a memo detailing his support for approval. “At the same time, patients with [Alzheimer’s] have a serious, progressive, ultimately fatal disease and are desperate for treatments.” The FDA made public its internal deliberations as it faces criticism from some doctors and scientists over the June 7 approval of the drug, called Aduhelm. An expanded version of this report appears on WSJ.com. Also popular on WSJ.com: What you can and can’t do if you’ve been vaccinated: Travel, gatherings, risk factors, what you need to know. American basketball pro spent eight months in secretive China detention.

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