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

The decision is not related to the product.

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

More from Europe

More from Geography