The full approval of Eisai and Biogen’s Leqembi (lecanemab) by the US Food and Drug Administration on 6 July is a milestone for the Alzheimer’s treatment market, and helps create a regulatory and market access pathways for late-stage candidates and future drugs.
Leqembi gained accelerated approval in January, but this was converted to a full approval by the US regulator based on the Phase III Clarity AD study, which showed that 18 months of treatment of Leqembi saw patients’ condition decline 27% less than those in the placebo group
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