US lawmakers launch investigation into FDA approval and price of new Alzheimer's drug

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Two House committees have launched an investigation into the approval and pricing of the Alzheimer's disease drug aducanumab, made by the company Biogen and sold under the brand name Aduhelm.
(CNN)

The US Food and Drug Administration approved the drug earlier this month under its "accelerated approval" program, although an FDA advisory committee concluded last year that there was not enough evidence to support the effectiveness of the treatment.

Biogen announced in early June that the wholesale cost of treatment -- which requires an infusion once every four weeks -- is about $4,312 per infusion, making the annual cost about $56,000 for a high dose.

"We have serious concerns about the steep price of Biogen's new Alzheimer's drug Aduhelm and the process that led to its approval despite questions about the drug's clinical benefit," House Democrats Carolyn Maloney and Frank Pallone Jr. said in a statement issued Friday about the investigation by the Committee on Oversight and Reform and the Committee on Energy and Commerce.

"We strongly support innovative treatments to help the millions of Americans who suffer from Alzheimer's disease, but Aduhelm's approval and its $56,000 annual price tag will have broader implications for seniors, providers, and taxpayers that warrant close examination," the statement said, noting that they sought to understand how Biogen set the price and what impact it would have on federal health care programs and other research.

Biogen told CNN in an email on Tuesday, "We will of course cooperate with any inquiry we may receive from these committees."

'The drug showed no good evidence that it worked'

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee concluded last year that there was not enough evidence to support the effectiveness of the drug -- and thus clinical data did not support approving the treatment.

Dr. Aaron Kesselheim, a Harvard Medical School professor and Brigham and Women's Hospital physician who resigned from the advisory committee after the approval of aducanumab, said last week that "the drug showed no good evidence that it worked."

Kesselheim, who was one of three committee members…
Jacqueline Howard, CNN
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