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Drug Approval Sparks Resignation

A member of the US Food and Drug Administration advisory panel that voted against approving the Alzheimer's disease treatment aducanumab has resigned following the agency's decision to approve the drug, according to Stat News.

The approval of aducanumab, Biogen's Aduhelm, was controversial, as whether it was effective is unclear. Biogen terminated trials of the drug after it appeared not to work as expected. But as Time magazine reported in 2019, a re-analysis of the data then suggested to the company that one trial showed that cognitive decline slowed among some Alzheimer's disease patients given the treatment and prompted it to seek FDA approval. FDA officials appeared to be in favor of approving the drug, as Stat News reported last November, but an outside advisory panel was not convinced the drug was effective, as NPR reported then, noting that the agency usually follows the recommendations of its outside advisors.

The agency, though, announced this week that it was approving Aduhelm under its accelerated approval pathway. According to Stat News, the agency had specifically told the panel in the fall that it was not considering accelerated approval and now in a letter to the panel chair says additional discussions later led it to consider that route.

Stat News reports that Washington University in St. Louis' Joel Perlmutter has now resigned from the advisory panel. In an email, Perlmutter tells it that he is stepping down "due to this ruling by the FDA without further discussion with our advisory committee."

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