STAT+: How Biogen found a believer: At the FDA, a hard-nosed regulator was won over on controversial Alzheimer’s drug
When the drug maker Biogen pitched its Alzheimer’s treatment to a panel of independent experts last November, most saw muddled, confusing data that raised doubts about whether it would benefit patients. Billy Dunn saw a “home run.”
Dunn, the Food and Drug Administration’s chief of neuroscience, told the experts that the data supporting Aduhelm were “extremely persuasive,” and, in a departure from the neutral tone that regulators typically strike, he called on the agency to “exercise the broadest flexibility” to approve the treatment. Seven months later, it did.
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