EMA Approves Alzheimer’s Drug Leqembi After Review
The European Medicines Agency (EMA) has reversed a previous decision and now recommends the approval of Leqembi (lecanemab) for the treatment of early Alzheimer’s disease. This decision provides new hope for patients with mild cognitive impairment or early-stage dementia caused by Alzheimer’s.
Initial Rejection and Reassessment
In the summer of 2024, EMA declined the initial application for market authorization, citing concerns that the moderate benefits of Leqembi did not outweigh the risks, including brain swelling and bleeding. Following a reassessment, the agency has concluded that the benefits of the drug now justify its risks.
Specific Conditions and Safety Measures
The approval is limited to patients carrying no more than one copy of the ApoE4 gene, a factor that reduces the likelihood of ARIA (amyloid-related imaging abnormalities) side effects. Treatment must occur under a specialized program requiring patients to undergo at least four MRI scans to monitor potential side effects. Additionally, the drug manufacturer Esai is required to establish an EU-wide registry to ensure the continued safety monitoring of treated patients.
Next Steps for Implementation in Sweden
Following EMA’s recommendation, formal approval by the European Commission is the next step. In Sweden, national implementation will require a recommendation from the NT Council, the Swedish Association of Local Authorities and Regions’ advisory body on new therapies.
For more details see article in Läkartidningen.
