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US FDA’s Small Adcomm For Eisai/Biogen's Leqembi Suggests Gaps In Conflict-Of-Interest Screening

 
• By Sue Sutter

Late recusal of several potential panelists was the result of a recent docket submission containing a December research community letter signed by dozens of Alzheimer’s experts, FDA said; signatories included neurologist David Weisman, who had received a conflict-of-interest waiver that cited his role in a Phase II lecanemab study but not in an ongoing Phase III study.

Gap in bridge
The FDA's conflict-of-interest screening process may have some gaps. • Source: Shutterstock

The small size of the US Food and Drug Administration advisory committee that weighed Eisai Co., Ltd. and Biogen, Inc.’s Alzheimer’s treatment Leqembi (lecanemab-irmb) for conversion from accelerated to regular approval seems to have highlighted some gaps in the agency’s conflict-of-interest screening and disclosure process.

A December 2022 letter signed by hundreds of Alzheimer’s disease researchers and clinicians precluded “several potential experts” from participating on the Peripheral and Central Nervous System Drugs Advisory Committee, the...

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