FDA Says New Alzheimer’s Drug Should Have Limited Use. What Are the Implications?

Under a new FDA rule, an Alzheimer’s drug will be used only to treat people in the early stages of the disease. MoMo Productions/Getty Images
  • The Food and Drug Administration is limiting the use of the drug Aduhelm to treat Alzheimer’s disease.
  • It’s now being recommended only for people in the early stages of the disease.
  • Medical professionals and officials at the Alzheimer’s Association say they support the limitations.

Following pushback and resignations over the decision to approve the use of Aduhelm to treat Alzheimer’s disease, officials at the Food and Drug Administration (FDA) narrowed their recommendations last summer for the drug to only be used to treat people in the early stages of the disease.

That pullback came just weeks after the approval of the drug, the first approved to treat Alzheimer’s in 18 years.

Medicare also launched a review on how — and if — they should cover the cost of the drug.

That review, a seldom-used process called “coverage determination,” will consider Aduhelm’s usefulness along with its price tag, said to be as high as $56,000 a year.

That decision could reduce access to the drug even more.

The revelations prompted officials at the Cleveland Clinic in Ohio and the Mount Sinai medical complex in New York to announce in July 2021 that they will not treat people with Aduhelm.

In February 2022, officials at the American Academy of Neurology released a review of clinical trial data on Aduhelm that concluded that the new drug did reduce amyloid plaques in the brain but stated the evidence was unclear on the drug’s effectiveness on Alzheimer’s symptoms.

The review also reported that side effects are common with the use of Aduhelm.

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