Brazil Approves Leqembi for Early Alzheimer’s Patients

Overview

• Anvisa’s approval was published in the Diário Oficial da União on December 22, registering lecanemab from Biogen and Eisai.
• The therapy is indicated for adults with mild cognitive impairment or mild dementia due to Alzheimer’s, contingent on tests confirming brain beta-amyloid.
• Patients carrying the APOE-e4 mutation are not eligible, and use requires specialist oversight with imaging and close monitoring for adverse events.
• Clinical trials reported about 27% slower decline over 18 months with intravenous infusions roughly every two weeks, with risks including brain edema, hemorrhages, infusion reactions and headaches.
• There is no price or launch date in Brazil, and experts say high costs make near-term availability in the public health system unlikely until CMED sets a maximum price.