FDA Mulls Over Approval Of Controversial Alzheimer’s Drug : NPR

The FDA is poised to decide whether to approve aducanumab, a drug to treat Alzheimer’s. It’s proved highly effective at removing the sticky amyloid plaques associated with the disease from the brain.


The Food and Drug Administration will decide whether to approve the first new drug for Alzheimer’s disease since 2003. Scientists disagree about whether it works. NPR’s Jon Hamilton reports.

JON HAMILTON, BYLINE: The drug is called aducanumab, and it’s designed to remove the sticky plaques that build up in the brains of people with Alzheimer’s. Harry Johns is the president and CEO of the Alzheimer’s Association. He’s also a big fan of aducanumab.

HARRY JOHNS: We believe strongly that if the FDA approves this treatment, it will be a new day for Alzheimer’s.

HAMILTON: John says the Alzheimer’s Association is supporting approval even though studies show the drug has at best a modest ability to slow down the disease.

JOHNS: This is not a cure. This is an incremental benefit potentially and that benefit can be very real in changing lives for so many.

HAMILTON: A panel of scientists who advise the FDA saw it differently. In November, they voted against approval, saying the drug failed to meet the usual scientific standards. But Johns says the panel took a narrow view, one that discounted the roughly 6 million people in the U.S. who have Alzheimer’s.

JOHNS: Scientific approaches that do not take into account the full science or the great need of the community that is affected today is not pro-patient.

HAMILTON: Aducanumab is being developed by the drug companies Biogen and Eisai. In 2019, the companies halted two major studies of the drug after preliminary results suggested it didn’t work. Then a reanalysis of the data produced a more favorable result, and the companies decided to seek FDA approval after all. Ultimately, the FDA was presented with one study showing the drug worked and another showing it didn’t. Dr. Jason Karlawish, who directs the Penn Memory Center at the University of Pennsylvania, says that’s not good enough.

JASON KARLAWISH: The data just aren’t there right now to say that this is the drug to open up the new era for the treatment of Alzheimer’s.

HAMILTON: Also aducanumab has side effects including bleeding and swelling in the brain. Karlawish says that means people taking the drug will need regular brain scans.

KARLAWISH: The uncertainty of whether it actually has a benefit means we would be introducing into practice a drug that does have risks and yet very well isn’t benefiting the individuals who are taking it.

HAMILTON: The uncertainty around aducanumab could mean a difficult decision for people with Alzheimer’s and their families. Dr. David Rind is with the Institute for Clinical and Economic Review, an independent nonprofit research organization.

DAVID RIND: If this drug is approved and people are considering taking it, they need to be aware that it’s quite possible that it does not work.

HAMILTON: Rind says FDA approval of aducanumab also could lead to the approval of other Alzheimer’s drugs whose efficacy is uncertain.

RIND: You could imagine a situation in which additional therapies instead of being compared to placebo would be compared to aducanumab. Does that mean it works or it doesn’t work?

HAMILTON: The FDA has indicated that it will make a decision by Monday. Jon Hamilton, NPR News.

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