Brazil Authorizes Leqembi for Early-Stage Alzheimer’s Treatment

Overview

• Anvisa authorized lecanemab (Leqembi), with the decision published in the Diário Oficial da União on December 22, 2025.
• The therapy is indicated for adults with mild cognitive impairment or mild dementia due to Alzheimer’s, contingent on confirmed brain amyloid, pre-treatment imaging and APOE‑e4 testing because of ARIA risk.
• The monoclonal antibody is administered as a one-hour intravenous infusion every two weeks in hospital settings.
• In a 1,795-person trial, lecanemab slowed decline on the CDR‑SB scale over 18 months, with reports of roughly a 27% reduction versus placebo.
• No Brazilian launch date or local price has been announced; CMED must set a maximum price, and U.S. list pricing is about US$26,500 per year.