New alzheimer’s drug aduhelm does not get eu approval gesundheitsstadt berlin

New Alzheimer's drug Aduhelm does not get EU approvalThe new Alzheimer's drug Aduhelm with the active ingredient aducanumab is not approved in Europe. The European Medicines Agency (EMA) made the decision due to a lack of evidence of efficacy and, in some cases, severe side effects. In the U.S., Aduhelm has been approved since summer, subject to conditions.

Although Aduhelm reduces beta-amyloid plaques in the brain, the new Alzheimer's drug has not been approved in the EU. The clinical benefit is not obvious – Photo: © Adobe Stock/ Chinnapong

The European Medicines Agency EMA has not approved the Alzheimer's drug aducanumab in Europe. This means that the active ingredient with the trade name Aduhelm will not be marketed in Germany either.

Risk-benefit balance led to rejection of marketing authorization application

In studies, the manufacturer Biogen was able to prove that aducanumab effectively removes the typical Alzheimer's protein deposits from beta-amyloid in the brain. But whether this also improves patients' cognitive abilities has not yet been proven. In addition, side effects, some serious, were observed in the studies. In 35 percent of patients, so-called amyloid-related injuries – ARIA for short – occurred, i.e. temporary swelling or microhemorrhages in the brain. Above this age, cognitive problems or confusion often worsen under therapy.

On the basis of this risk-benefit balance, the EMA has rejected the application for approval. In November, an external advisory panel had already come out against approval in Europe, and the EMA has now followed the recommendation.

EMA decides differently than FDA

In the USA Aduhelm is approved since summer under conditions. Approval was highly controversial due to the lack of proof of efficacy. The FDA had made the approval conditional on Biogen demonstrating the efficacy of the antibody in an additional study. If Biogen can show no appropriate data, Aduhelm will lose probably also its permission in the USA.

Alzheimer's research is on the move. Several new substances are in development that address the causes of dementia for the first time. read

Here's what Alzheimer's experts have to say about the EMA decision

From the perspective of the non-profit Alzheimer's Research Initiative, the EMA has made the right decision in view of the current study situation. The results of the two phase 3 trials to date are contradictory and do not convincingly prove that Aduhelm actually noticeably helps those affected, the AFI writes in a statement. He said it was gratifying "that the EMA did not follow the decision from the U.S. and approve a drug without proof of efficacy."

Beta-amyloid plaques are not everything

In addition to aducanumab, other agents are currently being studied in trials that target beta-amyloid plaques- Whether they are more promising is currently uncertain. The problem with Alzheimer's is that the disease is very complex and, in addition to beta-amyloid proteins, other disease mechanisms play a role, such as the tau protein or inflammatory processes.

The AFI therefore demands the broadest possible basic research. "Because we will probably not be able to cure Alzheimer's disease with one active ingredient, but rather combination therapies will be needed that individually target different disease mechanisms."

Similarly, Prof. Johannes Levin from LMU Klinikum Munich opposite Gesundheitsstadt Berlin. The September Conversation on Aducanumab. The state of Alzheimer's research can be found here.

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