Surprising decision - The EU authority rejects the recommendation for Alzheimer medicine
It was the first approved original Alzheimer therapy in the EU: Surprisingly, the EU Medicines Agency (EMA) in Amsterdam has spoken out against the approval of the Alzheimer drug Lecanemab. The risk of severe side effects of the antibody is higher than the expected beneficial effect, the EMA stated. The agency specifically referred to potential water accumulation and bleeding in the brains of people being treated with the drug.
"I was surprised by the decision," said neurologist Wenzel Glanz, head of the Memory Clinic at the University Clinic Magdeburg, to the German Press Agency (dpa). "We had already prepared for infusion therapies." The German Neurology Society (DGN) criticized the decision: "Europe is not only taking a special path but also promoting a two-tier medicine," it stated in a statement. "Those who can afford it will obtain the medication via the international pharmacy and have it administered in Germany."
The therapy slows down disease progression in early stages
Lecanemab, or Leqembi, has been available in the USA since early 2023 to treat Alzheimer's disease in the early stages. The therapy does not improve symptoms but can slow down disease progression in this stage by approximately 30%, according to studies. The antibody is therefore only suitable for a very limited number of Alzheimer patients, according to experts, for fewer than ten percent. In Germany, there are estimated to be around one million people affected.
Among the side effects are microbleeds and edema in the brain. Therefore, the therapy must be regularly monitored with MRI scans. The responsible committee of the EMA decided, according to the agency's announcement, "that the observed effect of the drug in slowing down cognitive decline does not outweigh the risk of serious side effects (...)."
Glanz, the expert from Magdeburg, can "conditionally understand" this decision. "Edemas and bleeds occur in about 30% of those treated," he told dpa. "Therefore, the therapy requires constant monitoring, for example through regular MRT scans."
The EMA's recommendation is necessary for the approval of medicines in the EU. The company Eisai, which had filed the application for EU approval, can reportedly apply for a re-examination within 15 days.
- Despite being the first approved original Alzheimer therapy in the European Union (EU), Lecanemab's EU Medicines Agency (EMA) approval in Amsterdam has been met with criticism due to its potential severe side effects.
- In Germany, neurologist Wenzel Glanz, head of the Memory Clinic at the University Clinic Magdeburg, expressed surprise at the EMA's decision against approving Lecanemab, as they had prepared for infusion therapies.
- Lecanemab, also known as Leqembi, has been available in the USA since early 2023 to treat Alzheimer's disease in the early stages, with studies indicating it can slow down disease progression by approximately 30%.
- The therapy's side effects include microbleeds and edema in the brain, making it necessary for regular monitoring with MRI scans.
- The responsible EMA committee has decided that the potential benefits of Lecanemab do not outweigh the risk of serious side effects, leading to the decision against its approval in the EU.
- The German Neurology Society (DGN) has criticized this decision, stating that Europe is promoting a two-tier medicine, with those who can afford it obtaining the medication through international pharmacies and having it administered in Germany.
