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.

Written byAnnie Melchor
| 3 min read
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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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    Stephanie "Annie" Melchor got her PhD from the University of Virginia in 2020, studying how the immune response to the parasite Toxoplasma gondii leads to muscle wasting and tissue scarring in mice. While she is still an ardent immunology fangirl, she left the bench to become a science writer and received her master’s degree in science communication from the University of California, Santa Cruz, in 2021. You can check out more of her work here.

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