Brazil's National Health Surveillance Agency (Anvisa) approved the drug lecanemabe, marketed as Leqembi, on Thursday, January 8, for patients with early-stage Alzheimer's. The monoclonal antibody, administered via infusion, slows disease progression in individuals with mild cognitive impairment and confirmed beta-amyloid protein in the brain. The approval marks progress, though it is not a cure.
Brazil's National Health Surveillance Agency (Anvisa) announced the approval of lecanemabe, an innovative monoclonal antibody for treating early-stage Alzheimer's disease. Indicated for patients with mild dementia and cognitive impairment, the drug requires confirmation of beta-amyloid plaques in the brain, linked to the neurodegenerative condition.
The approval study involved 1,795 participants in the disease's early stage. Comparing the lecanemabe-treated group to a placebo, efficacy was assessed using the CDR-SB scale, which measures symptom severity and daily life impact after 18 months. Administration is via one-hour intravenous infusions every two weeks.
Similar to donanemabe (Kisunla), approved by Anvisa in April last year, lecanemabe does not cure the disease but slows its progression by targeting sticky structures that damage neurons. "The approval of this medication offers a new treatment option for people with early-stage Alzheimer's," says neurologist Paulo Caramelli, a professor at UFMG. He notes that it scientifically validates amyloid protein as a therapeutic target.
Restrictions limit use to initial stages, with no or one copy of the ApoE ε4 gene, and exclude advanced-stage patients or those with contraindications like anticoagulant use. Risks include ARIA, abnormalities such as brain swelling or bleeding, requiring strict screening and monitoring with MRI. Caramelli stresses the need for specialized teams: "Follow-up requires periodic complementary exams, mainly MRI."
Previously, treatments only managed symptoms; now, options like this slow cognitive and functional decline, preserving independence longer.
