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Tags: fda | drug | approval | alzheimers | resignation

3rd FDA Panelist Resigns Over Approval of Alzheimer's Drug

3rd FDA Panelist Resigns Over Approval of Alzheimer's Drug
 (Kiosea39/Dreamstime.com)

By    |   Thursday, 10 June 2021 08:02 PM

Another member of the Food and Drug Administration's advisory panel resigned and called this week's approval of an Alzheimer's drug "probably the worst drug approval decision in recent U.S. history."

Harvard's Aaron Kesselheim made the claim as the third expert advisory panelist to resign in a letter to acting FDA Commissioner Janet Woodcock on Thursday, The Hill reported.

Mayo Clinic neurologist David Knopman and Washington University in St. Louis neurologist Joel Perlmutter have also resigned.

The FDA panel was nearly unanimous last November in advising against approval of Biogen's Alzheimer's drug Aduhelm, with 10 voting no and one voting uncertain, citing a lack of evidence the drug is effective.

"At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug's effect on brain amyloid was likely to help patients with Alzheimer's disease, but this pivotal question was not discussed at the Advisory Committee meeting, and its premise was specifically excluded from discussion," Kesselheim wrote.

"The decisions by FDA administrators to ignore the Advisory Committee's clear recommendations led to their approval of two highly problematic drugs that offered little evidence that they would meaningfully benefit patients suffering from these devastating conditions. This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the healthcare system."

The FDA also went against the advisory committee's recommendation against the approval of Eteplirsen to treat Duchenne muscular dystrophy in 2016, according to The Hill.

The Biogen treatment will cost $56,000, and the Kaiser Family Foundation released analysis Thursday finding the drug could cost seniors on Medicare $11,500 in annual copays and cost the program nearly $29 billion a year.

The intravenous treatment is not a cure and intends to reduce plaque in the brains of Alzheimer's patients. It is the first Alzheimer's treatment approved in nearly 20 years, according to The Hill.

Proponents of the approval believe it might give patients more time, and the FDA approved it on the basis that Aduhelm "is reasonably likely" to benefit patients and potentially slow their decline.

The approval permits Biogen nine years to complete clinical studies on the drug's long-term efficacy.

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Another member of the Food and Drug Administration's advisory panel resigned and called this week's approval of an Alzheimer's drug "probably the worst drug approval decision in recent U.S. history." Harvard's Aaron Kesselheim made the claim as the third expert advisory...
fda, drug, approval, alzheimers, resignation
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2021-02-10
Thursday, 10 June 2021 08:02 PM
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