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Aducanumab approved for treatment of Alzheimer's

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    Aducanumab approved for treatment of Alzheimer's

    The FDA approval of this drug has been controversial because the drug's efficacy hasn't been well established but one Alzheimer's organization is welcoming it:

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    SPMS diagnosed 1980. Avonex 2001-2004. Copaxone 2006-2009. Glatiramer acetate since December 2020.

    #2
    Controversy continuing as 3 FDA doctors resign in protest of the FDA approval of this drug:

    Only registered and activated users can see links., Click Here To Register...
    SPMS diagnosed 1980. Avonex 2001-2004. Copaxone 2006-2009. Glatiramer acetate since December 2020.

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      #3
      The FDA has decided to limit this drug's availability to those with mild symptoms of Alzheimer's disease:

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      In case readers are blocked by the New York Times's paywall, I'll try to post the article itself:

      In Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug


      The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. Now it recommends that the drug be given only to those with mild symptoms.
      A patient received an infusion of Aduhelm, the Alzheimer’s treatment, in Rhode Island last month.

      Credit...Pool photo by Jessica Rinaldi
      By Only registered and activated users can see links., Click Here To Register... and Only registered and activated users can see links., Click Here To Register...

      Published July 8, 2021Updated July 9, 2021, 3:12 p.m. ET

      Under fire for approving a questionable drug for all Only registered and activated users can see links., Click Here To Register...Only registered and activated users can see links., Click Here To Register... patients, the Food and Drug Administration on Thursday greatly Only registered and activated users can see links., Click Here To Register... and is now suggesting that only those with mild memory or thinking problems should receive it.

      The reversal, highly unusual for a drug that has been available for only a few weeks, is likely to reduce the approximate number of Americans who are eligible for the treatment to 1.5 million from six million.

      The approval ofOnly registered and activated users can see links., Click Here To Register... early last month was one of the most contentious F.D.A. decisions in years. Groups that represent Alzheimer’s patients had intensely lobbied the agency to sign off on the first new drug to treat the disease in 18 years — and the first ever designed to attack its biological underpinnings.

      But many Only registered and activated users can see links., Click Here To Register..., said there was not convincing evidence that the drug worked.

      In addition, the agency’s recommendation that Aduhelm be available to all Alzheimer’s patients, not just those showing early symptoms, stirred up Only registered and activated users can see links., Click Here To Register... among medical experts, including those who had supported the drug’s approval.

      After the approval, three members of the advisory committee Only registered and activated users can see links., Click Here To Register.... One, Dr. Aaron Kesselheim, described it as “the worst approval decision” that he could remember.

      The drug’s maker, Biogen, said last month that it would charge $56,000 annually for the drug. Associated costs — such as for diagnostics and safety monitoring, since the drug’s side effects include brain swelling and bleeding — could add tens of thousands of dollars to each patient’s annual bill.
      SPMS diagnosed 1980. Avonex 2001-2004. Copaxone 2006-2009. Glatiramer acetate since December 2020.

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        #4
        From JAMA (Medical News and Perspectives, July 21, 2021), "Recently Approved Alzheimer Drug Raises Questions That Might Never Be Answered":

        Only registered and activated users can see links., Click Here To Register...
        SPMS diagnosed 1980. Avonex 2001-2004. Copaxone 2006-2009. Glatiramer acetate since December 2020.

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          #5
          Since this thread has had a few page views, here's another article about this drug--from Consumer Reports (August 30, 2021):

          Only registered and activated users can see links., Click Here To Register...
          SPMS diagnosed 1980. Avonex 2001-2004. Copaxone 2006-2009. Glatiramer acetate since December 2020.

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