EMA’s CHMP finds path to Leqembi nod, backs three other new drugs

In a reexamination, EMA’s CHMP concluded that the benefit-risk profile of Alzheimer’s disease therapy Leqembi is positive if certain high-risk patients are excluded from treatment. 

The committee had initially recommended against approval of β-amyloid mAb Leqembi lecanemab from Eisai Co. Ltd. (Tokyo:4523) and  Biogen Inc. (NASDAQ:BIIB), citing modest benefit in the context of serious safety concerns. With much of the drug’s risk of brain swelling and bleeding concentrated in patients who carry two copies of the risk allele APOE4, CHMP now recommends approval of Leqembi but only patients who carry zero or one APOE4 allele...