FDA Advisory member has been recused from Biogen Review I wonder why this would be a shock to people that he was asked to stand down...
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By Deena Beasley
Nov 2 (Reuters) - The U.S. Food and Drug Administration, citing conflict of interest, has recused a member of an 11-person advisory committee set to review Biogen Inc's experimental Alzheimer's drug aducanumab on Friday.
Mayo Clinic neurologist Dr. David Knopman confirmed on Monday that he was recused from the scheduled meeting of outside advisors to the FDA. Expert advisory panels often play an important role ahead of FDA approval decisions, although the agency is not required to take their advice.
Knopman, who said he was recused because of his involvement in conducting clinical trials of aducanumab, has been a vocal critic of the drug, including in a paper published on Sunday in the journal Alzheimer's & Dementia.
"Aducanumab's efficacy as a treatment for the cognitive dysfunction in Alzheimer's disease cannot be proven by clinical trials with divergent outcomes," he wrote.
The FDA, which is slated to decide by early March whether to approve aducanumab, did not immediately respond to a request for comment.
If approved, aducanumab would be the first drug to treat an underlying cause of the fatal, mind-wasting disease, a field that has for decades produced nothing but failure. By 2025, the number of people age 65 and older with Alzheimer’s dementia is projected to reach 7.1 million in the United States alone, according to the Alzheimer's Association.
Biogen has said aducanumab, an antibody designed to remove harmful plaques from the brain, was shown in one of two major studies to significantly slow cognitive and functional decline. A second trial, however, showed a benefit only for a subset of patients who were given a high dose for at least 10 months.
Biogen abruptly ended a pivotal trial of aducanumab last year after an early look at results suggested it did not provide a desired benefit. Months later, the biotech company shocked many by reversing course, saying it had decided to seek FDA approval after all.