US Review of Biogen Alzheimer’s Drug Could Have Been Handled Differently: FDA Chief

Reuters
By Reuters
July 15, 2021USshare
US Review of Biogen Alzheimer’s Drug Could Have Been Handled Differently: FDA Chief
A sign for biotechnology company Biogen is seen on a building in Cambridge, Massachusetts, on March 18, 2017. (Dominick Reuters/AFP via Getty Images)

The U.S. Food and Drug Administration could potentially have done more to avoid the current controversies around its accelerated approval of Biogen’s Alzheimer’s drug, Aduhelm, FDA acting Commissioner Janet Woodcock said during a Wednesday summit hosted by Stat.

The FDA last week called for an independent federal probe into its representatives’ interactions with Biogen ahead of the regulator’s approval of Aduhelm last month.

“The accelerated approval was based on very solid grounds,” Woodcock said during Stat’s Breakthrough Science Summit. However, she said, “It is possible the process could have been handled in a way that would have decreased the amount of controversy involved.”

By Carl O’Donnell

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