Overview

• European regulators granted approval for Leqembi to treat early-stage Alzheimer's across all EU member states, as well as Norway, Iceland, and Liechtenstein.
• The approval follows a reconsideration process after initial rejection last summer due to side effect concerns, including risks of brain bleeding and swelling.
• Clinical trials demonstrated that Leqembi slows memory and cognitive decline by several months compared to a placebo, targeting sticky brain plaques linked to Alzheimer's.
• The drug, developed by Eisai and co-marketed with Biogen, is one of the first treatments to convincingly delay cognitive decline in Alzheimer's patients.
• While Leqembi moves forward, Eli Lilly's competing treatment Kisunla remains unapproved in Europe over similar safety concerns.