FDA adviser resigns in protest over agency’s Alzheimer’s drug approval

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The FDA used a controversial accelerated approval process

An adviser to the FDA has resigned over the agency’s speedy approval of a new Alzheimer’s drug. 

Earlier this week, the agency approved aducanumab, which goes by the generic name Aduhelm, for the treatment of Alzheimer’s disease. The FDA used an “accelerated” approval process, similar to the consideration it gave COVID-19 vaccines that received emergency use authorization last year. 

The expedited process drew concern from critics who said it received far less consideration than other drugs do before they’re brought to market. 

Mayo Clinic neurologist Dr. David Knopman, a member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), resigned from the committee in protest of the drug’s approval. In a Wednesday interview with CNN, he said he and the other external advisers decided there wasn’t enough evidence to support approving the drug and disagreed with the FDA’s decision to do so. 

"I resigned from the PCNS committee because if I ever were asked to serve on a future panel, I wouldn't have wanted to be treated in the disrespectful way that the aducanumab external advisers were treated," he said. "While I disagree with the decision to approve aducanumab, we in the clinical care and clinical research worlds will simply have to learn to adapt to the new circumstances."

Advisory committee uncertain

Aduhelm, which is given by infusion, is the first new drug to be approved to treat Alzheimer’s in nearly two decades. It was approved for use in patients with “mild cognitive impairment,” which often signifies that the patient is on the path to dementia.

Trials of the drug were paused in 2019 over a lack of promising results. However, Biogen -- the company that makes the drug -- took another look at the data last year. The company said the data showed that some patients who got high doses of the drug hadn’t improved, but they had shown a slower rate of decline than other patients. 

In November, the PCNS committee convened and voted against the suggestion that it could help patients. The panel decided they were “uncertain” about whether the drug had any effects on the brain. The FDA isn’t required to make decisions that are in line with the advice of its committees, but it usually does. That’s why the decision to approve the drug raised eyebrows. 

The FDA said this week that patients who received the treatment had a significant reduction of amyloid beta plaque, while patients in the control portion of the initial trials had no reduction of amyloid beta plaque. Critics of the drug’s approval say Biogen may have been motivated by money to get the drug approved, given that the drug would be priced at $56,000 a year.

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