Alzheimer’s drug Lecanemab awaits approval in the EU

Around a million people in Germany suffer from Alzheimer’s. Therapy with the antibody lecanemab could slow the progression of the disease. The European Medicines Agency is now in favor of approval.

The European Medicines Agency (EMA) has given the European Union the green light for the first time for an Alzheimer’s therapy that targets underlying disease processes. The agency recommended approval of the antibody lecanemab for the treatment of mild cognitive impairment, such as memory and thinking problems or mild dementia in the early stages of Alzheimer’s disease. Current Alzheimer’s therapies only treat symptoms of the disease, not the causal processes in the brain.

However, there is a limitation to the EMA recommendation: the drug should only be used for Alzheimer’s patients who have only one or no copy of ApoE4, a specific form of the gene for the protein apolipoprotein E. They are less likely to experience certain serious side effects, such as swelling and bleeding in the brain, than people with two copies of ApoE4.

Admission initially rejected

The EU Commission responsible for approval usually follows the authority’s vote. The manufacturers of Lecanemab, which has been sold in the USA under the brand name Leqembi since 2023, are the pharmaceutical companies Eisai from Japan and Biogen from the USA.

In July, the EU Medicines Agency rejected approval: The risk of serious side effects from the antibody was considered to be higher than the expected positive effect, it was said at the time. The manufacturers had requested a second test.

Regular checks necessary

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has now concluded that in the limited population examined in the re-examination, the benefits of lecanemab in slowing the progression of disease symptoms outweigh the risks. In the first review, no subgroup analyzes were taken into account, but all patients.

In its statement, the CHMP emphasizes that there must be measures to minimize risks. Patients would need to have regular MRI scans, as well as additional scans for warning signs such as headaches, visual disturbances and dizziness.

Funds should be available relatively quickly

In Germany, around a million people are affected by Alzheimer’s disease. The now recommended antibody lecanemab does not improve the symptoms, but is only intended to slow down the progression of the disease by removing the protein fragment beta-amyloid (Aß) from the brain. “Amyloid ß is probably at the beginning of a cascade of neuronal pathological changes in the brain,” said Jörg Schulz from the University Hospital of Aachen, spokesman for the “Dementia and Cognitive Disorders” commission of the German Society for Neurology.

Experts like Frank Jessen from the German Center for Neurodegenerative Diseases in Cologne assume that the drug will be available in Germany relatively quickly. However, it will probably take a while before there is a coordinated and responsible introduction of the therapy at the specialist centers. Jessen assumes that some doctors dispense the drug beforehand. “Because the pressure from patients is high. Many also say: I’ll pay for this out of my own pocket straight away.”