EMA Partially Approves Leqembi for Early Alzheimer's Treatment
Key Insights
The European Medicines Agency (EMA) has recommended granting marketing authorization for Leqembi (lecanemab) to treat mild cognitive impairment or mild dementia due to Alzheimer's disease (search).
The approval is restricted to patients with one or no copies of the ApoE4 (search) gene, who have a lower risk of amyloid-related imaging abnormalities (ARIA), including brain bleeding.
Leqembi, developed by Biogen and Eisai, is the first approved treatment that targets the early stages of Alzheimer's by clearing amyloid proteins in the brain.
The European Medicines Agency (EMA) has partially approved Leqembi (lecanemab), a new treatment for Alzheimer's disease (search), reversing an earlier decision. The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for Leqembi for treating mild cognitive impairment or mild dementia due to Alzheimer's disease, but only for a specific group of patients.
Developed by Biogen and Eisai, Leqembi targets adults experiencing mild memory and cognitive problems resulting from the early stages of Alzheimer's. The drug uses antibodies to bind to and clear amyloid proteins that accumulate in the brains of individuals with Alzheimer's, addressing the underlying pathology of the disease.
The EMA's initial rejection in July cited concerns over side effects, including potential brain bleeding. The current endorsement is contingent on restricting treatment to patients with one or no copies of the ApoE4 (search) gene, a known risk factor for Alzheimer's. These patients are less likely to experience amyloid-related imaging abnormalities (ARIA), such as fluid on the brain and brain bleeding.
Risk Minimization Measures
To mitigate risks, the EMA is implementing a controlled access program to ensure Leqembi is used only in the recommended patient population. This includes MRI scans before and during treatment to monitor for ARIA. The EMA stated that the benefits of Leqembi outweigh the risks in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease (search) with one or no copy of ApoE4 (search), provided that risk minimization measures are in place.
Clinical Impact and Availability
Clinical trials have shown that Leqembi can decrease cognitive decline by a quarter in people in the early stages of the disease. Lecanemab has been hailed by Alzheimer's researchers and charities for being the first approved treatment which tackles the early stages of the disease, rather than managing the symptoms. Britain's medicines regulator approved lecanemab in August, making it the country's first such licensed treatment.
The EMA's approval will now be sent to the European Commission for a final decision on rollout across the continent. Pricing and reimbursement will be determined by individual member states.