Posted by Michael Wonder on 27 Jul 2021
How Biogen found a believer: at the FDA, a hard nosed regulator was won over on controversial Alzheimer’s drug
27 July 2021 - 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 FDA’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.
