EMA does not recommend Alzheimer antibodies
The biologic Lecanemab is already approved in the USA, Japan, China, and South Korea under the trade name Leqembi for the treatment of early Alzheimer's disease. However, in the EU, this is not likely to happen soon. The risks of severe side effects, as stated by the EMA, are too high compared to the expected benefit.
The European Medicines Agency (EMA) has rejected the recommendation for the Alzheimer's drug Lecanemab. The risk of severe side effects of the biologic outweighs the anticipated beneficial effect, the EMA announced in Amsterdam. The agency specifically referred to potential water retention and bleeding in the brain of people treated with the drug.
Lecanemab, or Leqembi, has been available in the USA since early 2023 for the treatment of Alzheimer's disease in its early stages. The therapy does not improve symptoms but can slow down the disease progression in this stage. The drug is therefore only suitable for a very limited number of Alzheimer's patients, estimated by experts to be less than ten percent. In Germany, there are approximately one million people affected by the disease.
Recommendation is basis for approval in EU
Among the side effects are microbleeds and edema in the brain. Therefore, treatment must be regularly monitored with brain scans using magnetic resonance imaging (MRI). The responsible committee of the EMA decided, according to the announcement of the agency, "that the observed effect of the drug on the slowing down of cognitive decline does not outweigh the risk of serious side effects (...)".
"The EMA's decision will be disappointing for many, but there is also reason for hope: Lecanemab has shown that it is possible to slow down the progression of the disease, and research is ongoing," says Tara Spires-Jones from the University of Edinburgh, according to Science Media Center. Scientists around the world are approaching the problem from various angles. This ranges from inhibiting the spread of toxic Tau proteins in the brain to protecting the synapses that enable neuronal communication. Each discovery brings us closer to new and better treatment options, Spires-Jones adds.
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.
The EMA's decision to reject Lecanemab's approval for Alzheimer's treatment in the EU is based on the potential risks of severe side effects, such as water retention and brain bleeding, outweighing the expected benefits. This is contrary to the drug's approval in countries like the USA, where it's marketed as Leqembi and used primarily for early-stage Alzheimer's patients. Efforts to develop alternative treatments for Alzheimer's, such as inhibiting toxic Tau proteins in the brain or protecting neuronal communication synapses, are ongoing in the field of medical education and research.
