Approval recommended

EU: First green light for Alzheimer’s therapy

The European Medicines Agency (EMA) has given the green light for the first Alzheimer's therapy in the EU that targets the underlying disease processes. The authority recommended the approval of the antibody lecanemab for the treatment of mild cognitive impairment (memory and thinking disorders) or mild dementia at an early stage of Alzheimer's disease.

However, there is one restriction: the recommendation is that the drug should only be approved for Alzheimer's patients who have only one or no copies of ApoE4, a specific form of the gene for the protein apolipoprotein E. These patients are more likely to have certain severe dementia symptoms.

They are less likely to experience certain serious side effects - swelling and bleeding in the brain - than people with two copies of ApoE4. Other Alzheimer's therapies only treat the symptoms of the disease.

Second review after rejection
The EU Commission, which is responsible for approval, usually follows the vote of the authority. Lecanemab is manufactured by the pharmaceutical companies Eisai (Japan) and Biogen (USA). In July, the EU Medicines Agency had still rejected approval: the risk of serious side effects of the antibody was considered to be higher than the expected positive effect, it said. The manufacturer of the drug had applied for a second review.

Protein fragment is removed from the brain
The antibody, which has already been approved in the USA under the trade name Leqembi since the beginning of 2023, is intended to remove the beta-amyloid (Aß) protein fragment from the brain. "Amyloid ß is probably at the beginning of a cascade of neuronal pathological changes in the brain," said Jörg Schulz from Aachen University Hospital, spokesperson for the Dementia and Cognitive Disorders Commission of the German Neurological Society (DGN).