Anvisa Approves Leqembi for Early-Stage Alzheimer’s in Brazil

Overview

• The approval covers adults with mild cognitive impairment or mild dementia due to Alzheimer’s who have beta‑amyloid plaques confirmed by diagnostic testing.
• Leqembi (lecanemab) is given by intravenous infusion every two weeks and clinical studies reported about a 27% slower rate of cognitive decline over 18 months.
• Safety risks include amyloid‑related imaging abnormalities such as brain swelling and microhemorrhages, with higher risk in APOE‑e4 carriers, and the label calls for genetic testing before treatment.
• Use is contraindicated for patients with prior intracerebral hemorrhage, more than four microhemorrhages, superficial siderosis, vasogenic edema suggestive of cerebral amyloid angiopathy, or continuous anticoagulant therapy.
• The decision was published in the Diário Oficial da União on December 22, there is no announced Brazilian launch date or price, and U.S. pricing is about US$26,500 per year; donanemab (Kisunla) was cleared in Brazil earlier for a similar population.