The European Medicines Agency (EMA) has partially approved a marketing request for Leqembi (lecanemab), a new treatment for Alzheimer's disease. This decision reverses an earlier rejection and marks a significant step forward in addressing the early stages of this debilitating condition.
The EMA's recommendation grants marketing authorization for Leqembi in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease, specifically those with one or no copy of the ApoE4 gene. This genetic factor is known to influence the risk of amyloid-related imaging abnormalities (ARIA), including brain bleeding and fluid on the brain.
Leqembi, developed by Biogen and Eisai, is designed to target and clear amyloid proteins that accumulate in the brains of individuals with Alzheimer's disease. Clinical trials have demonstrated that the treatment can decrease cognitive decline by approximately 25% in patients in the early stages of the disease.
The EMA's endorsement is conditional, requiring strict risk minimization measures. These include a controlled access program to ensure the medicine is used only in the recommended patient population and mandatory MRI scans before and during treatment to monitor for ARIA. The agency emphasized that the benefits of Leqembi outweigh the risks in the specified patient group, provided these risk mitigation strategies are in place.
"The benefits of Leqembi outweigh the risks in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease with one or no copy of ApoE4," the EMA stated. This was "provided that risk minimisation measures are in place to reduce the risk of severe and symptomatic ARIA and monitor its consequences in the long term."
This decision follows a previous rejection by the EMA in July, which cited concerns that the side effects, including potential brain bleeding, outweighed the benefits. The current approval is based on a re-examination of the data and a focus on a specific patient subgroup with a lower risk profile.
The EMA's approval will now be forwarded to the European Commission for a final decision regarding its rollout across the continent. Pricing and reimbursement decisions will be determined by individual member states.
Lecanemab has been lauded by Alzheimer's researchers and charities as the first approved treatment to directly address the underlying pathology of the disease in its early stages, rather than merely managing symptoms. Britain's medicines regulator approved lecanemab in August, making it the country's first such licensed treatment. Leqembi, along with Aduhelm, received approval from the US Food and Drug Administration early last year.
