Safety of Alzheimer’s therapy again under scrutiny at EMA’s CHMP

The anti-amyloid saga continues at EMA’s CHMP, as the European Commission, in an uncommon move, has asked the committee to reconsider its recommendation to approve anti-amyloid mAb Leqembi lecanemab.

The EC said it was making the request due to new safety information that had come to light after CHMP had issued a positive opinion on Leqembi in November. That decision was based on a reexamination of the anti-β-amyloid mAb’s data and overturned the therapy’s initial rejection in July 2024, in which it had cited modest benefit in the context of serious safety concerns...