“We are losing the chance of a valuable and effective treatment for early-stage Alzheimer's disease"

The EMA recently decided not to approve the Alzheimer's drug Lecanemab (brand name: Leqembi) in the EU. This decision is incomprehensible to me and other experts. There is an urgent need for an effective treatment option that actually addresses the causes of the disease. Lecanemab is not a cure, but it can slow down the progression of Alzheimer's dementia if people are treated early. Lecanemab differs from previously approved therapies because it targets one of the causes of the disease rather than just the symptoms: The antibody attaches itself to the beta-amyloid proteins that accumulate in the brain in the form of damaging plaques in Alzheimer's disease, thereby enabling their targeted degradation by the immune system. As a result, the progression of the disease and the progression of cognitive and functional impairment are slowed, and patients are better able to cope with their daily lives. In the pivotal studies, these effects were sustained for several months compared to the control group.

The rejection was justified by the EMA on the grounds that the expected effect was not great enough to outweigh the risk of side effects associated with Lecanemab. Although Lecanemab can cause side effects in certain cases, these can usually be detected early and managed well through targeted screening to identify suitable patients and regular monitoring of the brain. In addition, treatment can initially be focused on patient populations where a favorable benefit-to-side effect ratio is expected. In addition, treatment could initially be limited to specialized centers such as memory clinics in hospitals.

Lecanemab represents a major advance, both in the medical treatment of Alzheimer's disease and in clinical research. The refusal to approve the drug in the EU deprives early-stage Alzheimer's patients of an important treatment option, thus reducing the quality of care compared to other countries. In addition, European Alzheimer's research could be left behind if no experience can be gained with this drug. There is also a risk of two-tier medicine, as wealthy patients could obtain the drug from international pharmacies and be treated as out-of-pocket payers.

Many experts, patients and their families in the EU had high hopes for Lecanemab and are now deeply disappointed. The manufacturer of the drug has announced that it will apply to the EMA for a new review for EU approval. In the interests of early-stage Alzheimer's patients in the EU, and in the interests of European medical excellence, it is hoped that the EMA will reconsider its decision and allow safe and well-controlled access to this drug.

Statements of DZNE experts on the refusal of "Lecanemab" by the European Medicines Agency