EMA Approves Lecanemab for Early-Stage Alzheimer’s Treatment in EU

The newly approved antibody therapy targets amyloid plaques to slow cognitive decline in select patients.

Lecanemab, marketed as Leqembi, has received approval from the European Medicines Agency after a previous rejection due to safety concerns.
The therapy is designed for patients with mild cognitive impairment or early-stage Alzheimer’s and has shown a 27% reduction in cognitive decline compared to a placebo.
Only a small fraction of Alzheimer's patients, particularly those without two copies of the ApoE4 gene, are eligible for treatment due to elevated risk of brain swelling and bleeding.
The treatment involves bi-weekly intravenous infusions and requires extensive pre-diagnosis testing, including genetic screening, to minimize risks.
Despite its potential, the therapy's implementation faces logistical challenges, including the need for specialized diagnostic infrastructure and ongoing patient monitoring.