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Big Drug, Small Panel: US FDA Adcomm For Eisai/Biogen’s Leqembi Includes Only Six Voting Members

 
• By Sue Sutter

Six is the fewest number of voting experts for a drug or biologic advisory committee dating back to at least 2015, according to the Pink Sheet Performance Tracker. Agency issued two conflict-of-interest waivers for the meeting, one of which was to a site principal investigator on lecanemab and aducanumab studies but who is no longer participating in the Leqembi review.

Half dozen eggs (2)
Leqembi's clinical benefit and safety will be evaluated by just a half dozen voting experts at a 9 June advisory committee meeting. • Source: Shutterstock

The US Food and Drug Administration panel that will weigh conversion from accelerated to regular approval for Eisai Co., Ltd. and Biogen, Inc.’s Alzheimer’s drug Leqembi (lecanemab-irmb) comprises only six voting members, representing the smallest advisory committee for a product-specific review in recent history.

Six members is the fewest number of voting experts at an advisory committee for a drug or biologic dating back to at least 2015, according to the Pink Sheet

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