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Leqembi’s EU Approval Process Delayed Over Advisory Group COI Considerations

The decision is not related to the product.

 
• By Lisa Takagi

The EU regulatory agency’s discussions for lecanemab’s approval are hit by a decision to annul advice from an advisory committee due to the implications of a Court of Justice ruling on the handling of experts' competing interests.

The court ruling led EMA to void the SAG-N decision for Leqembi due to potential COI concern.
The court ruling led EMA to void the SAG-N decision for Leqembi due to potential COI concerns • Source: Shutterstock

The European approval process for Eisai Co., Ltd./Biogen, Inc.’s Alzheimer’s disease drug Leqembi (lecanemab) has been delayed due to the unprecedented impact from a recent court ruling related to the European Medicines Agency’s conflict of interest policy.

Eisai announced on 22 March that the EMA had annulled the advice it obtained from its Scientific Advisory Group on Neurology (SAG-N) meeting on 11 March 2024 regarding lecanemab's potential approval and that the agency would hold another meeting, for which the schedule has not yet been decided. This also meant that Eisai's oral explanation meeting, which had been scheduled to take place on 19 March with the EMA's human medicines committee, the CHMP, did not go ahead

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