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Biogen’s quest to win approval for a new Alzheimer’s disease treatment once seemed futile. Now the company is sitting on what could be the most lucrative product in pharmaceutical history.

Hours after the Food and Drug Administration’s surprising approval of Aduhelm, the company’s controversial treatment for Alzheimer’s disease, Biogen set a list price that was nearly five times what Wall Street analysts had expected: $56,000 per year for the average patient.

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More good news for Biogen: Aduhelm’s label clears the drug for any and all patients with Alzheimer’s, not restricting its use, as widely expected, to the early-stage patients enrolled in the company’s clinical trials. On a call with reporters Monday, Peter Stein, director of the FDA’s Office of New Drugs, endorsed Aduhelm’s broad use, arguing that its ability to reduce amyloid plaques could offer a benefit to all patients with Alzheimer’s.

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