Conflicts Of Interest Delay Leqembi’s EU Approval

Eisai/Biogen’s Alzheimer’s drug has fallen foul of a recent court ruling over the handling of the European Medicines Agency’s experts' competing interests.    

EMA
• Source: Getty

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

The unexpected blow to lecanemab’s approval schedule in Europe is down to a ruling by the Court of Justice of the European Union on 14 March that has clarified the impartiality and independence requirements in the drug approval process at the EMA and may

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