Lecanemab wins full FDA approval (2023)
The US Food and Drug Administration (FDA) granted full approval to lecanemab, an antibody that clears amyloid-beta. In a roughly 1,800-patient trial, it slowed cognitive decline by about 27% over 18 months. Eisai and Biogen sell it as Leqembi.
Medicare agreed to cover the drug, opening access for older Americans.
It proved that removing amyloid can change the disease, though the benefit is modest and the drug carries brain-swelling risks.
Cu(ATSM) targets the same toxic protein by a different route. Lecanemab shows amyloid removal can win approval; it also shows the payoff for patients may be small.
