“Setback for Europe”: Alzheimer’s drug rejected

The risk of serious side effects of the antibody is higher than the expected positive effect. Elisabeth Stögmann, head of the special outpatient clinic at the Vienna General Hospital and president of the Austrian Alzheimer’s Society, spoke of a “setback for Europe” on Tuesday in the Ö1 morning journal.

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The authority had particularly pointed out the possibility of water retention and bleeding in the brain of people being treated with the drug. Therefore, therapy must be regularly monitored with magnetic resonance imaging (MRI) scans. The responsible committee of the EMA decided that “the observed effect of the drug in slowing cognitive decline does not outweigh the risk of serious side effects (…)”.

Therapy does not improve symptoms

In contrast, lecanemab – trade name Leqembi – has been available in the USA since the beginning of 2023 to treat early-stage Alzheimer’s. Although the therapy does not improve symptoms, it can slow the progression of the disease at this stage, according to studies by around 30 percent. The antibody would only be suitable for a very limited group, according to experts for less than ten percent of patients.

According to Stögmann, it is difficult to say whether the EMA decision is right or wrong. But: “From my point of view, it is definitely a setback for Europe, on the one hand on an individual level for affected patients who could potentially have received this therapy now, but also on a scientific level in terms of progress, because from my point of view and from the point of view of the entire international scientific community, it was a milestone in the development of therapy for Alzheimer’s disease.”

Differentiate in case of side effects

According to the doctor, a distinction must be made regarding side effects: 12 percent of patients experienced side effects, namely brain swelling. Only a third noticed this, the others were detected by magnetic resonance imaging. “That means they did not notice these side effects, and really serious side effects were noticed in one to two percent of people. You have to look closely at that, but it is a small percentage that could be minimized even further if you take a certain genetic risk constellation into account and do good imaging.”

If a new drug is rejected by the European Medicines Agency (EMA), there is always a balancing act behind it, said Markus Zeitlinger, head of the Department of Pharmacology at the Medical University of Vienna, also in the Ö1 morning journal. “And in this case, this combination did not lead to a positive benefit-cost ratio.”

Zeitlinger: “I think it’s very important that we act independently in Europe. I don’t want to say whether the FDA’s decision was right or whether the EMA’s decision was right, but I think it’s very important that we look at it in a differentiated way, because I think it’s important for patients to see that people are really racking their brains and not just because a domino falls and everyone else follows up, regardless of whether this decision is right or wrong.”