Alzheimer’s: EU authority rejects new antibody for treatment – with good reason

2024-07-26 13:10:56

Health Alzheimer’s

EU Commission rejects new antibody for treatment

Deadline: 27.07.2024 | Reading time: 3 minutes

In Germany, around one million people are affected by Alzheimer’s

Quelle: Getty Images / Halfpoint Images

There are great hopes for the antibody preparation Lecanemab for the treatment of Alzheimer’s. Now the EU Medicines Agency is against accepting the drug – with obvious reasons. What the experts say about it.

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DThe EU Medicines Agency (EMA) has rejected a recommendation for the Alzheimer’s drug lecanemab. The EMA announced on Friday in Amsterdam that the risk of serious side effects from the antibody is higher than the expected positive effect. The order specifically refers to the possible retention of fluid and blood in the brain of people treated with the drug.

Lecanemab – trade name Leqembi – has been available in the US since early 2023 for the treatment of early-stage Alzheimer’s disease. Although medical therapy does not improve the symptoms, it can slow the progression of the disease somewhat at this stage.

So the vaccine will be good only for a limited group of Alzheimer’s patients, according to experts, less than ten percent. In Germany, it is estimated that almost one million people have the disease.

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The EMA’s decision not to allow the drug on the European market is generating mixed reactions from Alzheimer’s researchers. Neuroscientist John Hardy from the UK Dementia Research Unit in London said: “I have to say I’m delighted with the decision. In contrast to the American FDA, which gave the new medicine the green light last year, the EMA has taken a more dubious position when it comes to the relationship between benefits and risks. “I’m sure that rich people with early-stage Alzheimer’s will fly to the US or other countries for treatment,” Hardy predicted.

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However, it seems clear that measurement is not easy. “Although he“This approval is a positive sign for further progress in the development of dementia drugs,” said Oxford psychiatrist Ivan Koychev. On the other hand, the cognitive benefits of lecanemab are balanced at best and occur in conjunction with significant side effects.” in the EU would have preferred if all eligible patients had received the preparation.

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Side effects of lecanemab that EMA pays special attention to include microbleeds and edema in the brain. Therefore, therapy must be monitored regularly with magnetic resonance imaging (MRI) tests. The responsible committee of the authority therefore came to the general conclusion that “the observed effect of the preparation in reducing cognitive decline does not exceed the risk of serious side effects”.

EMA support is essential for the approval of medicines in the EU. According to the order, the Eisai company, which submits an application for approval, can request a review within 15 days.