European Medicines Agency recommends refusal of marketing authorization of novel Alzheimer’s drug

The European Medicines Agency (EMA) has recommended the refusal of the marketing authorisation for the novel Alzheimer’s drug “Lecanemab” (brand name: Leqembi). EMA considered that the benefits of treatment are not large enough to outweigh the risks.

The drug has been approved in the USA, Japan, China, South Korea and other countries. It is intended for people with mild cognitive impairment or in the early stages of Alzheimer's disease. Lecanemab cannot cure the disease or stop its progression, but it can delay its progression somewhat. Possible side effects include microbleeds and swelling in the brain.

Unlike previous Alzheimer's drugs, Lecanemab does not just have a symptomatic effect, but also targets the molecular mechanisms and causes of the disease: specifically, it is a technically produced antibody that is administered by infusion. The antibody attaches itself to certain proteins (so-called beta-amyloid proteins that accumulate in the brain in Alzheimer's disease and helps to break them down.

Prof. Dr. Gabor Petzold, neurologist and Director of Clinical Research at DZNE, comments on the EMA’s decision and future developments in therapy:

“The risk-benefit ratio of lecanemab is indeed a matter of controversy. In view of the available data, it is generally understandable that the EMA has decided to take this cautious approach, but on the other hand, many patients, relatives and experts had hoped for a different decision. We should now closely monitor the use of lecanemab in countries where the drug has been approved. I am sure that the development of further therapies will benefit from this experience.”

“Alzheimer’s is a complex disease in which various factors interact. Further therapeutic options that target other, also relevant disease mechanisms beyond amyloid will have to follow. Possible approaches, in addition to so-called tau proteins, which also accumulate in the brain in Alzheimer’s, are inflammatory processes and cardiovascular comorbidities. The future probably lies in combination therapies. In any case, we cannot avoid investing even more in therapy research and also in prevention research. After all, preventing Alzheimer's would be even better than treating it.”

_{July 2024}