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Thread: In controversial decision, FDA approves first new Alzheimer's drug in nearly 20 years

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    Default In controversial decision, FDA approves first new Alzheimer's drug in nearly 20 years

    Jacqueline Howard
    Mon June 7, 2021

    The US Food and Drug Administration on Monday approved the use of the experimental drug aducanumab for early phases of Alzheimer's disease -- despite an FDA advisory committee concluding last year that there is not enough evidence to support the effectiveness of the treatment.
    The drug was developed for patients with mild cognitive impairment, not severe dementia, and intended to slow progression of Alzheimer's disease -- not just ease symptoms.
    The FDA has not approved a novel therapy for Alzheimer's disease since 2003.

    Keep reading: https://www.cnn.com/2021/06/07/healt...=1623148359849
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    Default Re: In controversial decision, FDA approves first new Alzheimer's drug in nearly 20 y

    "Bloomberg School epidemiologist Caleb Alexander recently warned that the FDA was poised to make an unfortunate decision: approving the controversial Alzheimer’s drug known as Aduhelm.
    Yesterday, the FDA did just that, approving the drug despite strong warnings from independent advisers, including Alexander, who overwhelmingly concluded that there was insufficient evidence that the treatment had significant benefits for patients.
    Aduhelm is the first new drug for Alzheimer’s disease in nearly 20 years—and the only drug that U.S. regulators believe can likely treat the underlying disease rather than manage symptoms like anxiety and insomnia. It is also expected to make billions for its maker, Biogen.
    But it hasn’t been shown to help slow the disease, and experts are concerned that it’s been allowed to skirt regulatory standards.
    “I’m quite surprised. The most compelling argument for approval was the unmet need but that cannot, or should not, trump regulatory standards,” Alexander told STAT. “It’s hard to find any scientist who thinks the data are persuasive.”
    He explained his position in detail in a co-authored op-ed for the New York Times."

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