Lawmakers Request Information About Alzheimer’s Drug Approval

The FDA granted the drug, called Aduhelm, accelerated approval earlier this summer in a process that’s since drawn scrutiny.

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Updates can be found at the end of the article; the most recent update is from April 22, 2022.

Two House committees sent a 13-page letter to acting US Food and Drug Administration Commissioner Janet Woodcock on Wednesday (September 1) as part of an investigation into the recent accelerated approval of a controversial drug for Alzheimer’s disease.

The letter—signed by representatives Carolyn B. Maloney (D-NY), chairwoman of the Oversight and Reform Committee, and Frank Pallone Jr. (D-NJ), chairman of the Energy and Commerce Committee—requested information about who was involved in the approval of the Biogen-produced drug and how the decision was made.

The drug—called Aduhelm—received accelerated approval from the agency on June 7, making it the first FDA-approved drug for Alzheimer’s in nearly 20 years. Aduhelm is supposed to remove amyloid-β plaques that accumulate in the brain, although some experts say plaque removal doesn’t slow disease ...

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    Annie Melchor

    Stephanie "Annie" Melchor is a freelancer and former intern for The Scientist.
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